93 Emplois - Merksplas
Senior Manager, Advanced Therapies Procurement
Aujourd'hui
Emploi consulté
Description De L'emploi
Procurement
**Job Sub** **Function:**
Category
**Job Category:**
Professional
**All Job Posting Locations:**
Beerse, Antwerp, Belgium
**Job Description:**
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at .
**_Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):_**
**_United States - Requisition Number:_** **R- **
**_Belgium - Requisition Number:_** **R- **
**_Switzerland - Requisition Number:_** **R- **
**_Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission._**
We are searching for the best talent for a Senior Manager, Advanced Therapies Procurement! This hybrid position will be located in Titusville, New Jersey (USA). Alternate hybrid locations may be considered in Beerse, Belgium; Zug, Switzerland; or Raritan, New Jersey (USA).
In the Innovative Medicine Supply Chain (IMSC) team, we are working to build a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat, and cure disease inspires us. We bring together the best minds and pursue the most promising science. Are you interested in joining a team delivering outstanding results to our customers? Apply now for this exciting opportunity!
The Senior Manager is responsible for global External Manufacturers and Critical Direct Materials and Service suppliers which bring unique capabilities to the Innovative Medicines Advanced Therapies (AT) platform. The category and spending are highly sophisticated and require close collaboration with team members within the business. Many of the innovative suppliers are early phase growth and require a supplier development mentality to support our scale. This individual will identify, develop, and lead the implementation of procurement goals and strategy as well as the organization's activities and deliver against targets for financial performance, quality, service, and compliance adherence. They will maintain key relationships within the business, manage key supplier relationships globally or regionally, and support the development of end-to-end category strategy and deployment.
**KEY RESPONSIBILITIES:**
+ Lead or support sourcing initiatives to identify the right supplier partners and build adequate material capacities to support business.
+ Influence business decision-making to deliver ongoing value improvements and drive competitive advantage.
+ Lead RFPs, applying e-sourcing systems effectively to drive speed to the market and decision-making internally through the tool.
+ Develop and/or support category sourcing strategy for defined portfolio through Business needs assessment, Market Intelligence, Supplier evaluations, and sourcing choices.
+ Proactively engage business partners and/or category managers to identify their needs and incorporate those needs into sub-category strategies.
+ Develop and lead supplier partnerships / external manufacturing partnerships to drive performance delivery, risk mitigation, and value through supplier-enabled innovation.
+ Mitigate business risk through the understanding of commercial, legal, and regulatory requirements and the use of efficient contracting channels demonstrating standard processes and technology.
+ Lead, support, or engage as a procurement authority in projects ranging from contracting, supply reliability, innovation, and new product development.
+ Represent procurement in end-to-end supply chain initiatives of manufacturing network, digital tools/ technology adoption, and resiliency.
**QUALIFICATIONS:**
**EDUCATION:**
+ Minimum of a Bachelor's/University or equivalent degree is required; advanced (MBA) degree or focused degree preferred in Business, Life Sciences, or related field
+ Certifications preferred: CPSM, CSCP, CPIM, or PMP/FPX
**EXPERIENCE AND SKILLS:**
**Required:**
+ Minimum 8 years of relevant work experience
+ Demonstrated experience in Strategic Procurement, Sourcing, Category Management, and/or Supplier Management, preferably in the Supply Chain Environment
+ Demonstrated ability to influence and shape projects without direct team/authority and effectively collaborate with differing view points of cross-functional partners and business leaders (e.g., Procurement, Marketing, R&D, and Supply Chain)
+ Demonstrated flexibility and willingness to respond to changes in the external environment, while ensuring the organization can effectively and efficiently move through transitions
**Preferred:**
+ Experience in end-to-end supply chain initiatives of manufacturing network, digital tools/ technology adoption, and/or resiliency
+ Experience in complex team member environment
+ Understanding of complexities of Regulated industries
+ Experience with global procurement for External Manufacturing, Materials, and Services
+ Strong business and finance competence
+ Proficient experience with one or more of the following areas: supplier performance, supply market analysis, and/or Procurement Excellence
**OTHER:**
+ Requires proficiency in English (written and verbal) to communicate effectively and professionally
+ May require up to 10% domestic & international travel
+ Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week
_#LI-Hybrid_
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                    Director, Global Nonclinical Writing and Submissions
Aujourd'hui
Emploi consulté
Description De L'emploi
Discovery & Pre-Clinical/Clinical Development
**Job Sub** **Function:**
Nonclinical Safety
**Job Category:**
People Leader
**All Job Posting Locations:**
Beerse, Antwerp, Belgium
**Job Description:**
About Innovative Medicine
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):
+ United States - Requisition Number: R-
+ Belgium - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Johnson & Johnson Innovative Medicine R&D is recruiting for a Director, Global Nonclinical Writing and Submissions. This position is a hybrid role and will be located in Beerse, Belgium.
The Director, Global Nonclinical Writing and Submissions, within the Preclinical Sciences and Translational Safety (PSTS) organization, will drive the nonclinical writing strategy and lead the team to deliver state-of-the-art submissions aligned with global requirements.
Principal Responsibilities:
+ Lead and mentor the nonclinical writing team, including internal and contracted writers, to meet pipeline goals with timely and high-quality deliverables (e.g., Investigator's Brochures, IND/CTA/NDA nonclinical modules, briefing books, health authority responses) across all programs and development phases.
+ Review of documents prepared by writers and ensure adherence to standards, quality, and strong positioning of key messages and risk assessment.
+ Maintain awareness of global submissions landscape and ensure nonclinical submissions strategy evolves to produce state-of-the-art, compliant deliverables.
+ Ensure consistent support and implementation of best practices across portfolio and maintain adherence to standard operating procedures and regulatory requirements in partnership with nonclinical, statistical, clinical, regulatory, and quality colleagues.
+ Collaborate effectively with leaders across PSTS and Johnson & Johnson Research and Development to ensure appropriate readiness for submissions within the portfolio from pre-portfolio to post-registration phases.
+ Manage timelines and resources; ensure early identification and timely communication of submissions-related issues and develop contingency plans proactively to address issues.
Qualifications:
+ A minimum of a Master's degree in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline is required. Advanced degree (PharmD, Ph.D. or equivalent) in Biomedical Sciences, Toxicology, Pharmacology, or a related discipline is preferred.
+ A minimum of 10 years of relevant experience is required in nonclinical writing and submissions supporting diverse modalities and therapeutic areas is required.
+ A minimum of 4 years of direct people management experience is required.
+ Strong knowledge of nonclinical drug development is required.
+ Strong knowledge of global submissions requirements is required.
+ Strong change/process management experience is required.
+ Knowledge of Good Laboratory Practice (GLP) and data security/integrity standards required.
+ Must have excellent communication and interpersonal skills with the ability to assure full clarity on intent and audience specific content.
+ Must have strong negotiating, troubleshooting and organizational skills.
+ The ability to work effectively in a collaborative environment and to help coach and mentor staff similarly is required.
+ This position will require up to 10% domestic and international travel.
#LI-Hybrid
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                    EM/Logistic analyst - early-shifted late
Aujourd'hui
Emploi consulté
Description De L'emploi
Non-Standard
**Job Sub** **Function:**
Workday Associate B
**Job Category:**
Non-Standard
**All Job Posting Locations:**
Beerse, Antwerp, Belgium
**Job Description:**
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at CAR-T**
CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system. They are created from the patients' own T cells and are engineered to eliminate cancer cells expressing a specific antigen.
**We are searching for the best talent for a EM/Logistic analyst - early-shifted late, to be in Beerse.**
To support the CAR-T program in EMEA, Janssen has built two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories are located on the existing Janssen Beerse site.
The EM/Logistic analyst, QC CAR-T Europe is responsible for shipment of Environmental Monitoring samples, Drug Product samples and Critical Reagents. Next to that also the incubation and read-out of Environmental Monitoring samples will be part of your responsibilities. All activities should be following the applicable procedures, standards, and GMP regulations.
This job will be in a 2-shift regime: Early/Shifted late (6:00h-14:00h and 12:00h-20:00h)
**You will be responsible for:**
+ Environmental Monitoring testing: Receival and unpacking of the shipment, incubation, read-out of result
+ Perform EM testing in compliance with all applicable specifications, procedures, GMP regulations
+ Drug Product Shipments, receival, unpacking and storage, including assigning the right storage locations to the different samples for all different temperature conditions (-120°C/-80°C/2-8°C)
+ On-Site transport of Critical Reagents
+ Copy of COA results in eLims for gowning, cleaning and other consumables
+ General administrative related QC tasks
+ Maintain a safe work environment in compliance with all applicable environmental, health, and safety regulations
+ Support laboratory related investigation records and CAPAs
+ Provide input to functional laboratory meetings
**Qualifications and requirements:**
+ A minimum of two (2) years of experience working in a cGMP compliant EM and or logistic function is required.
+ Experience in Environmental Monitoring testing is a plus.
+ Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) is required.
+ Excellent written and oral communication skills in Dutch are required
At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
**Here's what you can expect:**
+ **Application review:** We'll carefully review your CV to see how your skills and experience align with the role.
+ **Getting to know you:** If there's a good match, you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
+ **Staying informed:** We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
+ **Final steps:** For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
Finally, at the end of the process, we'll invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process!
#RPOEMEA
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                    Distribution Process, Data & Integration Lead
Hier
Emploi consulté
Description De L'emploi
Supply Chain Deliver
**Job Sub** **Function:**
Warehouse & Distribution
**Job Category:**
People Leader
**All Job Posting Locations:**
Beerse, Antwerp, Belgium, La Louviere, Hainaut, Belgium
**Job Description:**
Johnson & Johnson Innovative Medicine is recruiting for a **Distribution Process, Data & Integration Lead.**
Are you a strategic leader with deep expertise in distribution processes and digital transformation? Do you thrive in complex global environments and enjoy driving innovation and operational excellence? This role offers a unique opportunity to shape the future of supply chain operations at **Johnson & Johnson** .
**About the Role**
Reporting to the Johnson & Johnson Innovative Medicine VCM organization, the Distribution Process, Data & Integration Lead will act as the single point of accountability for deploying the distribution strategy, securing cross-functional alignment, catalyzing innovation, and sustaining the process blueprint for Johnson & Johnson Distribution processes and strategy in support of the Transcend/TIME program.
This Senior Manager will build and lead a network of distribution-domain subject-matter experts to define business processes, drive organizational alignment on key decisions, and ensure adoption of new processes.
In governance forums (for example, the Global Process Council), they will represent the Distribution area to maintain process integrity, influence decisions, champion change, and collaborate with JJT and the Global Product Owner to define, validate, and implement solutions aligned with the designed blueprint.
As the Distribution Process, Data & Integration Lead, you will be a subject-matter expert in Johnson & Johnson Innovative Medicine Distribution processes, focusing on enabling, standardizing, and innovating core business process definitions to meet critical business needs. This will be achieved through close collaboration with key stakeholders, a deep understanding of current business requirements, benchmarking, continuous improvement, and consistent process documentation via a standardized blueprinting approach.
**Key Responsibilities**
+ Support the Transcend Johnson & Johnson One Distribution process, driving global S/4 HANA core capability standardization, alignment, and adoption. Act as a Change Champion within the distribution community and stakeholder forums to promote harmonization.
+ Design, build, validate, and deploy distribution processes globally, ensuring alignment with the global template. Maintain a global and business-focused mindset, manage issue escalation and business risks, and define clear acceptance criteria to support end-to-end processes. Collaborate closely with business teams to map upstream and downstream distribution steps in an integrated way.
+ Lead and manage execution of operational Business Simulation and User Acceptance Testing activities. Develop and implement a standardized approach using standard testing tools. Support quality compliance system validation and change control processes to ensure ongoing compliance and good practices.
+ Provide insights and support for training and compliance documentation, and establish processes for ongoing updates. Maintain deep business process knowledge and ensure documentation within the knowledge center.
+ Lead a team of 1 to 10 people, owning the people and performance management process for the team.
**Other Duties**
+ Identify emerging digital technologies and opportunities. Shape innovation with an outside-in approach through white papers, webinars, and other channels. Advise leadership on critical topics and processes.
**Qualifications**
**Must-Have**
+ A minimum of a bachelor's degree is required. A master's degree in engineering, supply chain, or a related field is preferred.
+ Minimum of 10 years of overall business experience, preferably with a focus on supply chain distribution processes, technology, and strategy in large regional or global programs.
**Required Skills**
+ Project management experience; certifications in PMI or FPX.
+ Lean and Six Sigma experience; Green Belt required, Black Belt preferred.
+ Strong analytical and problem-solving skills.
+ High awareness of quality and compliance standards.
+ Excellent communication and stakeholder management skills.
+ Deep understanding of distribution processes and industry trends.
_*An internal pre-identified candidate for consideration has been identified. However, all applications will be considered._
**Additional Information**
This role offers a unique opportunity to contribute to the future of **Johnson & Johnson Supply Chain** , with a focus on innovation, standardization, and global collaboration. If you're ready to make a difference and support our mission, we encourage you to apply today!
**Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, protected veteran status, or disability.**
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                    QC Micro analyst (weekend shift)
Hier
Emploi consulté
Description De L'emploi
Non-Standard
**Job Sub** **Function:**
Workday Associate B
**Job Category:**
Non-Standard
**All Job Posting Locations:**
Beerse, Antwerp, Belgium
**Job Description:**
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at Janssen Supply Chain Group, a member of the Johnson & Johnson family of companies, is recruiting QC Micro analysts for the CAR-T hub in Europe. The position will be based in Beerse Belgium.
CAR-T (chimeric antigen receptor T-cell therapy) is an innovative approach to eliminate cancer cells, which work by harnessing the power of a patient's own immune system. They are created from the patients' own T cells and are engineered to eliminate cancer cells expressing a specific antigen.
**We are searchong for the best talent for a QC micro CAR-T (weekend shift), to be in Beerse.**
To support the CAR-T program in EMEA, Janssen has built two CAR-T manufacturing centers in the Ghent area (Belgium). The QC laboratories will be operated from the existing Janssen Beerse site.
The QC Micro analyst, CAR-T Europe is responsible for preparing and conducting testing of the different samples taken during the production process. You are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations.
The candidate will be part of the weekend team, working on Saturday and Sunday. Working hours will be from 6am to 6pm.
**You will be responsible for:**
+ Perform analytical testing in compliance with all applicable specifications, procedures, GMP regulations.
+ Maintain a safe work environment in compliance with all applicable environmental, health, and safety regulations.
+ Perform peer review of laboratory data.
+ Author and update SOPs, WIs and Protocols to support daily operations of the lab using the Document Management System.
+ Support laboratory related investigation records and CAPAs.
+ Assist in the execution of internal audits.
+ Provide input to functional laboratory meetings.
+ Provide input and take actions as a QC representative at cross-laboratory meetings.
**Qualifications:**
+ A minimum of a bachelor's degree in a Scientific or related field is required
+ A minimum of two (2) years of experience working in a cGMP compliant QC laboratory or equivalent is required.
+ Understanding data generated from performing microbiological techniques is required.
+ Detailed knowledge of Microbiological technologies, aseptic techniques used in the QC micro laboratory (CAR-T experience) is required.
+ Experience in performing endotoxin testing, grow promotion testing, sterility testing & environmental monitoring testing is required.
+ Basic knowledge of compendial (USP, EP, JP, etc.) requirements pertaining to their functional area of QC is preferred.
+ Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) is required.
+ Excellent written and oral communication skill are required.
At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
**Here's** **what you can expect:**
+ **Application review:** We'll carefully review your CV to see how your skills and experience align with the role.
+ **Getting to know you:** If there's a good match, you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
+ **Staying informed:** We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
+ **Final steps:** For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide youthrough these.
Finally, at the end of the process, we'll invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process! #RPOEMEA
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                    Quality Assurance Lab Associate
Publié il y a 2 jours
Emploi consulté
Description De L'emploi
Quality
**Job Sub** **Function:**
Quality Assurance
**Job Category:**
Professional
**All Job Posting Locations:**
Beerse, Antwerp, Belgium
**Job Description:**
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way. Learn more at are searching for the best talent for QA lab associate QC to be based in Beerse !**
This role focuses on ensuring laboratory compliance, with accurate and timely review of investigations and careful analysis of QC data to identify trends that can drive quality improvements. You'll be part of a collaborative quality team that partners across functions to strengthen regulatory readiness and continuous improvement. This is a role that values initiative, learning, and contributing to a culture of safety and quality!
**As a QA lab associate QC you will:**
**·** Provide compliance oversight for the laboratories, ensuring accurate and timely review of laboratory investigations, performing analysis on quality indicating data and identifying any trends noted for QC data.
**·** Support drafting and approving of standard operating procedures.
**·** Perform spot-checks in the Lab to ensure compliance with written regulations, policies, procedures, and global procedures.
**·** Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
**·** Strive to reduce non-conformances in supported areas by proactively driving compliance.
**·** Provide compliance oversight for analytical instrument qualification.
**Qualifications/Requirements:**
**·** A minimum of a Master Degree in Engineering, Science or equivalent technical discipline.
**·** A minimum of 2 years of experience in Quality Assurance.
**·** Knowledge of cGMP regulations.
**·** Knowledge of FDA/EU guidance.
**·** Experience in methods like flow cytometry , PCR , Elisa , Endotoxine testing
**·** Experience with cell counting and viability.
At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
**Here's what you can expect:**
**·** **Application review:** We'll carefully review your CV to see how your skills and experience align with the role.
**· Getting to know you:** If there's a good match, you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
**· Staying informed:** We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
**· Final steps:** For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
Finally, at the end of the process, we'll invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process! #RPOEMEA #LI_Hybrid
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                    IM Transcend Program Quality Lead
Publié il y a 2 jours
Emploi consulté
Description De L'emploi
Quality
**Job Sub** **Function:**
Digital Quality
**Job Category:**
People Leader
**All Job Posting Locations:**
Beerse, Antwerp, Belgium, Diegem, Flemish Brabant, Belgium, Gent, East Flanders, Belgium
**Job Description:**
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at are searching for the best talent for** **IM Transcend Program Quality Lead role.**
**Purpose:** IM Transcend is a multi-year global business transformation initiative that will modernize our end-to-end business digital capabilities by harmonizing our disparate ERP ecosystem, standardizing our core business processes and products (across Commercial, R&D, Plan, Source, Make, Quality, Deliver, and Data), and enabling our integrated data strategy through a single SAP S/4 HANA instance.
Quality standards that need to be followed within technology programs originate from a variety of sources: regulators, internal quality standards, internal policies, product standards, procedural norms, etc.
The Program Quality Lead applies the specifications of the corporate and organizational Quality Systems and Quality Standards to ensure that the quality of processes and deliverables of programs continuously meet their specified corporate and regulatory requirements. In addition, the Program Quality Leader will be involved in the assessment of potential external partners and in the evaluation and tracking of remedial activities of such partners.
The PQL may be called up to manage Quality-oriented sub-tasks within a technology project, including but not necessarily limited to: supplier evaluation, validation, risk assessment, risk mitigation, audit follow-ups, etc.
The Lead will need to develop strong business partnerships across key stakeholder groups, including (but not limited to) the IM, Commercial, R&D, Quality, Regulatory, Enterprise Quality Central Finance program (CFIN), EPM, JJT, and Enterprise Sourcing.
**You will be primarily responsible for** **:**
**Quality Management Framework**
+ Establishment of defined quality management framework for the program.
+ Define quality practices for project or program
+ Define and embed required quality-driven templates in the program
+ Drive documentation of quality practices in SOPs (QM)
+ Review and/or approve quality relevant deliverables (e.g. stage gate relevant content)
+ Principle author of key quality-driven project deliverables (e.g. validation documentation functional risk assessments, etc.) in alignment with relevant compliance experts (via a Document Factory)
**Ensuring quality execution for the Transcend program**
+ Monitor processes to ensure compliance with accepted framework, methodology, or quality standards (e.g. SDLC)
+ Manage validation projects/sub-projects (PQM)
+ Provide robust oversight of the risk management process
+ Coordinate quality documentation/deliverables
+ Work with the Testing Lead(s) to ensure testing adequately addresses program quality requirements.
+ Ensure that testing is adequately documented to ensure reproducibility.
+ Drive an efficient program quality framework, harmonizing the requirements from different frameworks
+ Drive measurable continuous quality improvements e.g. % right first time through TQ reviews"
**Establishing a Documentation Factory for the program**
+ Complete vendor selection (assuming RFP has already been initiated before the incumbent in in seat), in collaboration with procurement
+ Define Documentation Governance Framework, Operating Model, Tools
+ Define documentation scope and standards
+ Select documentation tools and repository setup
+ Create documentation templates
+ Develop documentation plan and schedule
+ Define quality assurance/review process
+ Onboard vendor documentation team
+ Assign SMEs for content walkthroughs
+ Review and approve deliverables
+ Track progress and resolve issues
+ Handover documentation to BAU teams
**Acting as the Program Quality "Advocate** " with key stakeholders and as a Quality Consultant for the team
+ Possess a high level current knowledge of the regulatory compliance landscape. Know whom to contact for deeper regulatory advice (e.g. ICFR, ISRM, TQ, BQ, Data Privacy etc.).
+ Provide guidance to project teams on current program standards and quality practices. Be an SDLC SME.
+ Develop and align on "Golden Templates" with the relevant Quality functions
+ Collaborate and partner with the Quality functions, providing advocacy and influence for the program's approach to quality.
+ Maintain an active network with other quality managers and peers within compliance groups.
**Qualifications / Requirements:**
+ Bachelor's/University or equivalent degree in Quality/Business/IT/Science or comparable experience. MBA preferred.
+ Minimum 15 years of progressive experience in leadership roles within Quality, and ideally also Supply Chain, or large transformation programs.
+ Minimum of 10 years of progressive experience with GxP regulated processes in the pharmaceutical industry, preferably Quality Assurance, Supply Chain, Manufacturing or HSE (Health, Safety & Environment).
+ Hands-on experience of applying Business Quality (GXP) in an ERP setting, preferably using Agile methodology.
+ Required experience of applying SDLC principles in an ERP setting.
+ Minimum 3 years of hands-on experience working in CSV IT Projects.
+ Deep knowledge of IM Quality across all functions required.
+ Demonstrated hands-on project management/delivery required. Experience in management of project timelines and milestones in complex business environments required.
+ A highly respected expert in the Quality Function.
+ Ability to effectively lead and govern cross-functional decision-making bodies required.
+ Good Technical Writing and GDP (Good Documentation Practice) skills as the PQM has to author major validation documents like Validation Plans, Reports and other documents. Additionally, knowledge in deploying standardized work processes, tools, and templates required.
**OTHER:**
+ Requires proficiency in English (written and verbal) to communicate effectively and professionally.
+ May require up to 20% of domestic and international travel.
+ Requires the ability, through our flexible work policy, to work on-site a minimum of three days each week, with the option for two remote workdays each week.
#LI-Hybrid
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À propos du dernier Tous Emplois dans Merksplas !
JJT Tech Product Owner (TPO) ERP Master Data, Sr. Manager
Publié il y a 2 jours
Emploi consulté
Description De L'emploi
Technology Product & Platform Management
**Job Sub** **Function:**
Technical Product Management
**Job Category:**
People Leader
**All Job Posting Locations:**
Beerse, Antwerp, Belgium
**Job Description:**
We are seeking the best talent for a **JJT Tech Product Owner (TPO) ERP Master Data, Sr. Manager** to be located in Beerse, Belgium.
Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements.
While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s)
+ Titusville, NJ, Malvern, PA or Horsham, PA - Requisition Number: R-
+ Beerse, Belgium - Requisition Number: R-
Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.
Pharm Transcend is a global business transformation program that will modernize our foundational transactional processes and harmonize them into one "clean" ERP as a standardized platform for growth and efficiency gains. The program will simplify the Pharm ERP landscape from 7 to 1, standardizing processes in order to have a cost effective, fit for purpose digital backbone that will enable us to support the Pharm business with agility. Additionally, the program will remediate the end-of-life system exposure that we risk towards the end of this decade.
As part of the Pharm Transcend Program, we are looking for a strong leader that can set direction and can drive
implementation based on proven knowledge and experience in the field of ERP Master Data and Data Migration.
The JJT TPO ERP Master Data is responsible for global standardization within Janssen of ERP technology solutions in the Master Data area. The TPO leads design, validation, and delivery of SAP S/4 capabilities and data aligned with business process needs. The position governs the scope of the SAP S/4 template and drives template innovation and evolution through the deployments. The role will lead the creation and ongoing evolution of our global data design, data standards, enabling fundamental and strategic capabilities that will fundamentally transform our Pharma business.
The JJT TPO ERP Master Data role will lead all aspects of JJT design, build and delivery for master data, data workflow and data migration for Pharm Transcend, enabling strategic data capabilities, human centered design, and data integration across our digital ecosystem. The role will partner closely with the Pharm Transcend business process and
data owners, SCT ecosystem and various vendor partners to ensure end to end capabilities are supported and evolved. The role will also operate closely with the Pharm TranSCend deployment organization to grow and evolve the capabilities as business and regional deployments are executed.
This individual must leverage a refined, multi-functional toolset of expertise with the SAP family of products, including S4, BODS, SLT, LSMW / DMC, ERP master data expertise, data integration, supply chain business expertise, process improvement, execution of transformative initiatives, global deployments, and digital acumen to effectively interact with a breadth of business stakeholders and global process owners. The position will partner closely with senior leaders within Pharm supply chain to ensure the evolving business requirements are being considered and met through optimal use of data and digital capabilities.
**Major Duties & Responsibilities**
Strategy & Roadmap
+ Own vision and prioritization of Pharm Transcend data capabilities to meet business needs including Data Design, Data migration, integration and establishing Master Data governance processes.
+ Establish technology roadmaps to achieve efficient & effective delivery of business & customer value for ERP Data requirements and data migration
+ Drive data standardization and approve design for Material Master, Production Master, Customer Master, Supplier Master, Asset Master and SC Finance Master data areas.
+ Balance business value with technical feasibility while prioritizing features, optimizing cost and improving delivery efficiency.
+ Lead Data Product Owners as they prioritize their backlogs, manage product / platform constraints and resolve cross-team dependencies; manage demand intake as required
Accountable for Product Design & Solutioning
+ Accountable for solution design and implementation of Data capabilities for Pharma Supply Chain on the ERP platform and data integrations with the ERP ecosystem, including MDG application.
+ Drive Business Process standardization and approve design for Material Master, Production Master, Customer Master, Supplier Master, Asset Master and SC Finance Master data areas within the scope of migration, MDG and S/4 implementation.
+ Identify any gaps and approve appropriate solutions.
+ Define the data migration approach in close collaboration with the Plan-Source, Make/Quality, Deliver/OTC, Logistics and Finance workstream leads.
+ Align data migration of Material, Customer and Vendor with workflow solution for within MDG platform.
+ Actively identify and address all compliance and regulatory requirements for the module.
+ Lead Data Product Owners as they prioritize their backlogs, manage product / platform constraints and resolve cross-team dependencies; manage demand intake as required.
+ Actively engage with business and functional teams in providing the best fit solutions while aligning to TranSCend program design and implementation standards
+ Drive selection of product / platform solution options, work with the Engineering team to assess tech elements of the solution prior to user testing and to balance tech debt.
Accountable for Delivery
+ Accountable for technical delivery and value realization in partnership with the business workstream lead.
+ Accountable to manage the integrated build with the Engineering team to ensure the end-to-end build of a particular part of a solution is compliant and works as designed
+ Own and lead planning and execution overall data migration including (Technical Testing, data loads, defect management,by Engineering team; Support business workstream lead to plan and execute User Acceptance Testing
+ Lead and manage compliance requirements associated with data migration within scope of responsibility, data validation, installation qualification of toolset, and associated SDLC documentation, system configuration and compliance activities are up to date as required.
+ Drive continual measurement of capabilities against demand volume, complexity, business challenges and improvement within value stream(s)
+ Building strong partnerships with business at different levels of the impacted organizations to understand the business's needs and priorities.
+ Negotiate with the business to see what items are built and which are backlogged based on capacity, business value and priority.
+ Partner with Technology Services on the software engineering approach to build and sustain the solutions
Leadership
+ Shape the IT Product governance and Data Quality reports on the ERP Master Data pillar
+ Act as the JJT workstream lead for all ERP Data topics including migration, partnering closely with Supply Chain Master Data Business Owner and stakeholders.
+ Mobilize and lead an international cross regional project team of ERP and Data technology experts through project design, execution, and deployment phases, integrating MDG as a core component for Master Data governance activities.
+ Coordinate, lead, coach, motivate and inspire the team to both deliver on agreed plans and to continuously improve.
+ Partner with other JJT teams in Supply Chain, Commercial, Finance and R&D on all integration topics. Resolve business and technical challenges and ensure realization of business benefits.
+ Escalate issues that cannot be resolved internally and implement aligned solutions.
+ Help Shape and Grow JJT organization to enable a global intake, build and sustain process that will drive parallel program releases and on-going operations, projects and enhancements as TranSCend goes live.
+ Foster an environment of continuous improvement and innovation.
**Qualifications**
**Required** :
+ A minimum of a Bachelor's degree
+ A minimum of 10 years of relevant experience
+ A minimum of 5 years relevant SAP experience
+ Strong Knowledge of SC Business processes - Order to Cash, E Commerce, Retail, Distribution and Warehouse Management including planning, procurement, quality management, order processing, pricing, shipping, and invoicing.
+ Strong knowledge of ERP data design, data migration approaches and data migration compliance deliverables across all phases of program (data validation, IQ, validation reports, scripts etc.)
+ Experience working across multiple levels of business and IT stakeholders.
+ Knowledge of technology trends and to apply this knowledge to data capabilities.
+ Understanding of ERP SAP functionality, including MDG.Ability to determine capabilities and technology limitations of S4 and migration toolset (BODS, SLT, DMC)
+ Ability to think creatively about where business initiatives drive technology evolution and to break-down processes and reinvent enabling technology capabilities with partners is required
+ Demonstrated strong sense of urgency in completing deliverables, excellent written and oral communication skills, strong negotiating/ influencing skills, self-starter with excellent interpersonal skills are required
+ Ability to work effectively in highly matrixed organization and dealing with high levels of ambiguity is required.
+ Strong personal commitment to continuous business improvement, and effectively collaborating and managing our business stakeholders
+ Ability to translate business requirements into Technical Epics/Stories.Experience working across multiple levels of business and IT stakeholders.
+ Proficiency in ERP/SAP S4 systems, particularly in master data management and related modules (material, vendor, and customer).
+ Capable of working as part of a team and on own initiative. Capable to change priorities quickly and influence others to do so.
+ Ability to embrace changes and to deliver IT solutions in a fast changing business/IT environment.
+ Previous experience in working in a global, cross-functional capacity is required.
+ Self-starter with collaboration abilities and ability to shape/lead complexity is required.
+ Experience with Agile methodology and strong understanding of the Software Development Lifecycle Management model and documentation
+ Good Knowledge with SOX, GxP compliance processes
**Preferred:**
+ GxP, SOX, Regulatory, Quality & Compliance, ERP, PLAN.
+ Excellent understanding of product planning and execution, knowledge of healthcare, business theory, processes, management, budgeting and business office operations.
+ Lean requirements gathering and story mapping experience.
+ Ability to pick up technical and business concepts quickly.
+ Proactively creates and communicates deep industry and business insights, excellent written and oral communication skills, excellent interpersonal skills, ability to motivate in a team-oriented, collaborative environment, exceptional service orientation, strong negotiating skills.
+ Able to create context around key business drivers and strategic plan, able to present ideas in business-friendly language.
#JNJTECH
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                    QC CAR-T Investigation Coordinator
Publié il y a 5 jours
Emploi consulté
Description De L'emploi
Quality
**Job Sub** **Function:**
Quality Assurance
**Job Category:**
Professional
**All Job Posting Locations:**
Beerse, Antwerp, Belgium
**Job Description:**
**About Innovative Medicine**
Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.
Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.
Learn more at is an innovative blood cancer treatment that uses the strength of the patient's own immune system. The patient's T-cells are genetically modified to eliminate the cancer cells. This advanced technology offers hopeful prospects to patients for whom other therapies provide no or insufficient results. We are therefore working passionately on expanding our capacity for CAR-T treatments in Europe, both at our existing site in Beerse and in Ghent, where we have developed a new production site. We are looking for strong talents who are eager to participate in this innovative and hopeful venture.
**We are searching for the best talent for a QC CAR-T Investigation Coordinator, to be in Beerse.**
Your tasks and responsibilities with the QC team are the following:
+ Support daily operations within QC, work closely together with supervisors, analysts, production, warehouse and QA.
+ Leading investigations and writing a final investigation report based on a thorough
+ root cause analysis. You define, implement corrective actions and monitor their effectiveness, ensuring timely execution and closure. If it concerns a cross-departmental QC investigation, you will manage a multi-disciplinary team. You are the QC representative in cross-departmental investigations.
+ Supporting and implementing improvement projects for the team in the areas of safety, quality, efficiency and customer satisfaction.
+ Develop training/awareness sessions within QC.
**Qualifications**
+ A minimum of a Master's degree in a biochemistry and biotechnology related degree
+ Knowledge of cGMP regulations and FDA/EU guidance is required.
+ High organizational skills and independent and flexible way of working are required.
+ Excellent written and oral communication skills are required
+ Professional experience in a GMP-regulated environment, preferably in the area of quality control, is an advantage
+ Very good knowledge of using Microsoft Office programs
+ A good knowledge of laboratory processes and systems is preferred
At Johnson & Johnson, we want every candidate to feel supported throughout the hiring process. Our goal is to make the experience clear, fair, and respectful of your time.
**Here's what you can expect:**
+ **Application review:** We'll carefully review your CV to see how your skills and experience align with the role.
+ **Getting to know you:** If there's a good match, you'll be invited to a short call with one of our recruitment team to understand more about you and answer any questions that you might have.
+ **Staying informed:** We know waiting can be hard and processes can evolve; our recruitment team will keep you updated and make sure you know what to expect at each step.
+ **Final steps:** For successful candidates, you will need to complete country-specific checks before starting your new role. We will help guide you through these.
Finally, at the end of the process, we'll invite you to share feedback in a short survey - your input helps us continue improving the experience for future candidates. Thank you for considering a career with Johnson & Johnson. We're excited to learn more about you and wish you the best of luck in the process! #RPOEMEA
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                    Medical Technologist Cryopreservation
Publié il y a 5 jours
Emploi consulté
Description De L'emploi
Non-Standard
**Job Sub** **Function:**
Workday Associate B
**Job Category:**
Non-Standard
**All Job Posting Locations:**
Beerse, Antwerp, Belgium
**Job Description:**
Bij Johnson & Johnson geloven we dat gezondheid alles is. Onze innovatieve kracht in de gezondheidszorg stelt ons in staat te bouwen aan een wereld waarin complexe ziekten kunnen voorkomen, behandeld en genezen worden. Een wereld waarin behandelingen slimmer en minder invasief zijn en oplossingen op maat gemaakt zijn. Door onze expertise op het gebied van innovatieve geneesmiddelen en medische technologiebevinden we ons in een unieke positie om te innoveren in het volledige spectrum van de gezondheidszorg en zo doorbraken te realiseren die een grote impact hebben op de gezondheid van mensen wereldwijd. Meer informatie vind je op Innovatieve Geneeskunde**
Onze expertise op het gebied van innovatieve geneeskunde wordt geïnformeerd en geïnspireerd door patiënten, wier inzichten onze wetenschappelijke vooruitgang voeden. Mensen met een visie zoals jij werken in teams die levens redden door de medicijnen van morgen te ontwikkelen.
Sluit je bij ons aan om behandelingen te ontwikkelen, genezingen te vinden en de weg te banen van het laboratorium naar het dagelijks leven, terwijl we patiënten bij elke stap van het proces ondersteunen.
Ga voor meer informatie naar is een innovatieve behandeling tegen bloedkanker, die gebruik maakt van de kracht van het eigen immuunsysteem van de patiënt. Het is een complexe en gepersonaliseerde technologie waarbij de eigen T-cellen van een patiënt uit het bloed geïsoleerd worden en opnieuw worden geprogrammeerd om kankercellen te herkennen en uit te roeien. Deze vooruitstrevende technologie biedt vooruitzichten voor patiënten bij wie andere therapieën geen of onvoldoende resultaat behalen.
**Je bent verantwoordelijk voor:**
+ Instaan voor de eerste stap in het productieproces van CAR-T: jij voert de formulatie- en cryopreservatieprocessen uit voor witte bloedcellen.
+ Streven naar de hoogste kwaliteit na en past de geldende regelgeving en standaarden toe.
+ Meewerken aan de optimalisatie van onze processen. Jouw ervaring en input zijn cruciaal om onze aanpak verder te versterken.
**Jouw Impact:**
+ Je vormt een cruciale schakel in ons productieproces.
+ Je maakt deel uit van een hecht team dat borg staat voor topkwaliteit.
+ Je werkt in een dynamische omgeving die persoonlijke en professionele groei stimuleert.
**Kwalificaties:**
+ Een bachelor in laboratoriumtechnologie, biochemie, chemie, of een gerelateerd vakgebied of gelijkwaardig door relevante werkervaring in een sterk gereguleerde omgeving b.v. in de farmaceutische, voedingsmiddelen-, chemie- of biotechsector.
+ Bereidheid om in shiften te werken een dag en late regime ,een week de dagshift en de week erop late.
+ Bereidheid om op zaterdag te werken.
+ Sterke aandacht voor detail en kwaliteit.
+ Verantwoordelijkheidszin in het toepassen van procedures en richtlijnen.
+ Goede communicatievaardigheden in Nederlands en Engels.
**Ons sollicitatieproces**
Bij Johnson & Johnson willen we dat elke kandidaat zich ondersteund voelt tijdens het sollicitatieproces. Ons doel is om de ervaring duidelijk, eerlijk en respectvol te maken voor jouw tijd.
**Wat kun je verwachten:**
+ **Beoordeling van je sollicitatie:** We bekijken je cv zorgvuldig om te zien hoe jouw vaardigheden en ervaring aansluiten bij de functie.
+ **Kennismaking:** Als er een goede match is, word je uitgenodigd voor een kort gesprek met een van onze recruiters om meer over jou te weten te komen en eventuele vragen te beantwoorden.
+ **Op de hoogte blijven:** We begrijpen dat wachten lastig kan zijn en dat processen kunnen veranderen; ons recruitmentteam houdt je op de hoogte en zorgt ervoor dat je weet wat je bij elke stap kunt verwachten.
+ **Laatste stappen:** Voor succesvolle kandidaten moeten land-specifieke controles worden afgerond voordat je aan je nieuwe functie begint. Wij begeleiden je hierbij.
Tot slot nodigen we je aan het einde van het proces uit om feedback te geven via een korte enquête - jouw input helpt ons om de ervaring voor toekomstige kandidaten te blijven verbeteren. #RPOEMEA
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