29 Emplois pour Quality Control - Belgique
Quality Control Analyst
Publié il y a 3 jours
Emploi consulté
Description De L'emploi
QC Analyst – Legend Biotech Gent
Role Overview
Ready to make a real impact on patients' lives and embark on an exciting new adventure? Join our Quality Operations Team in Ghent, where your passion for quality will drive you to exceed your own expectations. We're not just about striving for excellence; we believe in having a blast while doing it. If you're eager to grow, innovate, and have fun with a fantastic team, then you're in the right place with us!
What Can You Expect?
As a QC analyst, you will play a critical role in ensuring the highest quality of life-saving cell therapy products. Here's what you'll do:
• Advanced QC Testing: You will perform QC testing for CAR-T products in IPC laboratories and ensure compliance with all procedures, standards and GMP regulations.
• Environmental monitoring: You verify clean room classification by taking samples of (non-) viable particles and microorganisms.
• Collaboration: You will work closely with the Quality and Operations departments to bring analytical testing from the test bench to production.
• Documentation and data management: You will review and approve QC data, maintain process integrity through accurate documentation, and manage test results in our eLIMS software.
• Process Optimization: You will create and review QC documents, SOPs and work instructions and also contribute to process optimizations.
Who Are We Looking For?
Education:
• You have a bachelor's degree in lab technologies or other related field, or equivalent experience.
• We don't accept candidates with a Master degree
Experience:
• Practical experience in an aseptic production facility within QC or QA is a plus but certainly not a must. We offer you the necessary training to get you started in your new role.
Languages:
• You have strong written and oral communication skills in both Dutch and technical English.
Strengths:
• You are well organized, you can multitask and you are a real team player
What Do We Offer You?
• A meaningful job with an excellent work-life balance. You will work 4 days. After that you will enjoy 4 days off.
• A supportive and innovative work environment. We value and encourage learning and personal development.
• The opportunity to work with people from all over the world.
• A contract of indefinite duration and an attractive salary package complemented by many fringe benefits, such as additional statutory vacations, meal vouchers, group and hospitalization insurance, double vacation pay, an end-of-year and performance bonus.
• Many fun and informal events.
Quality Control Analyst
Publié il y a 4 jours
Emploi consulté
Description De L'emploi
We are seeking a detail-oriented and highly motivated QC Analyst to join our Quality and Operations team. As a QC Analyst, you will play a critical role in ensuring the quality and compliance of products and processes by performing analytical testing, maintaining accurate documentation, and supporting continuous improvement initiatives. This position is ideal for someone with a passion for quality assurance and analytical methods in a regulated environment.
Key Responsibilities:
- Analytical Testing: Perform routine and non-routine testing of raw materials, in-process samples, and finished products using different analytical.
- Compliance: Ensure that all testing is conducted in compliance with GMP, GLP, and regulatory guidelines.
- Documentation: Accurately document test results, deviations, and observations in laboratory notebooks and electronic systems.
- Troubleshooting: Identify and investigate deviations or out-of-specification results, ensuring proper corrective actions are implemented.
Practical
Rotating shifts (4 days on, 4 days off)
Quality Control Manager
Publié il y a 4 jours
Emploi consulté
Description De L'emploi
Introduction:
Based in Gembloux, Intressa Vascular is a clinical-stage company developing an innovative medical implant to address life-threatening cardiovascular conditions such as aortic dissection.
Our mission is to help physicians address the devastating effect of aortic dissection by delivering next-generation endovascular treatment.
To strengthen our team, we are looking for a Quality Control Manager to play a key role in ensuring product quality and compliance throughout our production processes.
Job purpose:
Reporting to the Operations Director, the Quality Control Manager is responsible for implementing and executing inspection and testing activities to ensure components, intermediate products, and final products comply with defined specifications, internal procedures, and regulatory requirements.
Duties and Responsibilities:
He/She is responsible, in a proactive and results-driven manner to:
- Coordinate and monitor subcontracted laboratories for outsourced testing activities to ensure that test requests, specifications, and results comply with internal requirements and regulatory standards.
- Establish and perform incoming, in-process, and final product inspections; define control plans, protocols, and inspection methods to ensure product compliance.
- Implement inspection routines and test protocols according to ISO 13485 and other applicable regulatory standards; support the review of product risks from a quality control perspective and contribute to process monitoring.
- Perform and oversee the use, maintenance, and calibration of inspection and measurement equipment, ensuring reliability and traceability of control activities.
- Author and maintain quality system documentation; manage traceability and archiving inspection records, certificates, and batch files.
- Prepare and provide documentation required for internal and external audits by notified bodies, customers, and suppliers.
Profile:
- Industrial or Civil Engineer in the fields of Mechanics, Electromechanics or Biomechanics.
- A minimum of 5 years of relevant experience in an industrial environment, in the medical device (preferred).
- Strong knowledge and understanding of risk management and quality management system principles (ideally ISO 13485 – ISO 9001 – GMP/GLP).
- Knowledge and practice of product design control and process validation according to medical device regulation (EU and USA).
- Roll-up-your-sleeves attitude, autonomous and hands-on mindset
- Excellent communication skills (written and verbally) and strong problem-solving abilities.
- High level of attention to detail, excellent organizational skills and time management.
- Fluent in French and English, written and spoken.
Our offer:
- A challenging and diversified position within a high-potential innovative medical device company.
- A human-sized, collaborative, and respectful work environment.
- An attractive compensation package in line with the position responsibilities and your experience.
Senior Quality Control Analyst
Aujourd'hui
Emploi consulté
Description De L'emploi
Context
Nuclear medicine has advanced significantly in recent years with the development of radiotherapeutics for cancer treatment. These radiotherapeutics deliver radioisotopes to cancer cells, where their decay emits radiation that selectively destroys tumors. Among these therapeutic isotopes, alpha-emitting Actinium-225 (Ac-225) is highly promising and is being utilized by pharmaceutical companies to develop new radiotherapeutics.
A key challenge is producing high-quality Ac-225 in large quantities. To address this, SCK-CEN and IBA have combined their expertise to establish PanTera, a company dedicated to producing Ac-225 and making it accessible to the pharmaceutical industry.
Purpose of the Position
PanTera is launching a new production facility to manufacture large quantities of Ac-225. This facility includes a specialized Quality Control (QC) laboratory responsible for ensuring the quality of Ac-225 produced. The QC lab will perform analyses to confirm that Ac-225 meets specifications for safe patient administration, adhering to current Good Manufacturing Practices (cGMP). The lab will employ advanced techniques such as gamma spectrometry and ICP-MS.
As a Senior QC Lab Analyst, you will work within the QC team under the direct supervision of the QC Manager. Your role will involve supporting the startup of new equipment, developing analytical methods (e.g., ICP-MS, gamma spectrometry, and Ac-225 labeling experiments), and contributing to equipment qualification and method validation. Given the cGMP-regulated environment, familiarity with GMP standards is essential.
We seek a candidate with a strong analytical mindset, excellent organizational skills, and a proactive, flexible approach to teamwork. The candidate should be eager to learn new analytical techniques and comfortable working with radioactive materials.
Key Responsibilities
- Qualify equipment and develop methods for analyzing Ac-225 solutions using specialized techniques (e.g., ICP-MS, gamma spectrometry, endotoxin determination).
- Analyze in-process control samples, starting materials, and Ac-225 batches using techniques such as gamma spectrometry and ICP-MS.
- Ensure all qualified equipment and analytical methods comply with cGMP regulations.
- Report data according to standard protocols.
- Manage quality control of raw materials (incoming goods).
- Perform (re)calibration and maintenance of laboratory equipment.
- Write and maintain Standard Operating Procedures (SOPs).
- Collaborate with subcontractor analytical laboratories as needed.
Profile
- Master’s degree in Analytical Chemistry or a related field.
- Proven experience with ICP-MS.
- Experience in radiochemical analysis.
- Familiarity with a GMP environment.
- Willingness to learn new analytical techniques and work under strict regulatory requirements.
Skills and Competencies
- Proficiency in specialized techniques such as ICP-MS and gamma spectrometry.
- Strong analytical skills with a keen eye for detail.
- Ability to work independently and collaboratively within a team.
- Quick learner, adaptable to a fast-paced and evolving environment.
- Commitment to adhering to high standards, cGMP, and regulatory requirements.
Our Offer
- A unique opportunity to work in a cutting-edge environment, contributing to the production of critical radiotherapeutics for cancer treatment.
- A collaborative workplace with supportive colleagues who value teamwork.
- An entrepreneurial atmosphere within a scaling company.
- A mission-driven organization focused on improving patients’ quality of life.
Head of Quality Control
Publié il y a 3 jours
Emploi consulté
Description De L'emploi
Are you a strong people manager with a passion for quality and technology? At SABCA Limburg, we are looking for a Lead Quality Control & Labo to lead two teams: the Quality Control team (QC & NDT) and the physical testing laboratory. You will be responsible for organizing, coaching, and supporting your team efficiently, while helping ensure that we meet the high-quality standards of the aerospace industry.
Together with your teams, you play a key role in ensuring the quality of components for the F-35 and other cutting-edge aerospace and space projects.
Your Responsibilities
Leadership and Coaching
- Lead both the QC/NDT team and the lab team (approximately 12 employees).
- Coach, motivate, and support team members in their technical development and soft skills.
- Conduct evaluations, development discussions, and plan training programs.
- Organize and plan team activities, monitor progress, and set priorities.
- Ensure the team meets its goals in terms of quality, timing, and output.
Organization and Follow-Up
- Ensure efficient task distribution within your teams.
- Oversee the accurate and timely execution of quality controls on production parts.
- Foster strong collaboration with other departments (production, engineering, maintenance, etc.).
- Monitor inspection output and ensure that any non-conformities are quickly reported back to production (RDR within 48h).
- Ensure day-to-day communication through daily production meetings and maintain up-to-date SQCDP and QC boards.
Quality and Process Improvement
- Ensure compliance with EN9100 and ISO14001 standards.
- Support continuous improvement projects related to quality, efficiency, and customer satisfaction.
- Keep procedures and testing methods up to date, and optimize them when needed.
- Manage the calibration planning for lab equipment and measurement tools.
- Analyze trends in non-conformities and contribute to structural improvements.
Your Profile
- Master’s degree in Chemistry, Mechanical Engineering, or Materials Science, or equivalent through experience.
- Relevant experience in quality or a lab environment, ideally in an industrial or production context.
- Knowledge of aerospace standards (EN9100, EASA) or composites is a strong plus.
- Leadership experience or a clear ambition to take on a team lead role.
- Strong knowledge of physical testing methods, quality control processes, and calibration is a major advantage.
- Structured, analytical, and results-driven.
- Strong communication skills, with a collaborative and motivating approach to leadership.
- Fluent in Dutch and English; knowledge of French is a plus.
What do we offer?
- A permanent contract with an attractive salary package, depending on your experience.
- A company car with fuel card, complemented by other extra-legal benefits such as meal vouchers, eco vouchers, hospitalization insurance, and more.
- A dynamic and exciting environment within the aerospace and aviation technology sector.
- We work a 39-hour week, which means 20 statutory vacation days plus 6 additional compensation days (ADV).
- Flexible working hours – a healthy work-life balance is definitely possible!
Ready to join the SABCA team? Apply now and become our next Head of Quality!
Quality Control Laboratory Manager
Publié il y a 4 jours
Emploi consulté
Description De L'emploi
KELA, opgericht in 1941, is een Belgische farmaceutische bedrijvengroep. KELA is een betrouwbare ontwikkelaar, producent en verdeler van veterinaire farmaceutische producten en voedingssupplementen van excellente kwaliteit. Via een uitgekiend netwerk van distributeurs verkopen we deze wereldwijd in meer dan 100 landen. We zoeken mensen die gepassioneerd zijn door gezondheid, nieuwsgierig zijn naar wat komt en die fier zijn om bij KELA te werken. Als je enthousiast bent om deel uit te maken van een resultaatgerichte organisatie, waar teamwork vanzelfsprekend is en kritisch denken in het DNA zit, dan hoor je thuis bij ons!
Functie
In deze sleutelrol ben je verantwoordelijk voor het aansturen en verder professionaliseren van de fysicochemisch, stabiliteiten en microbiologische Quality Control teams (circa 45 personen).
Je creëert een positieve, resultaatgerichte teamcultuur waarin kwaliteit, veiligheid en samenwerking centraal staan. Als QC Manager combineer je people management met een sterke focus op procesoptimalisatie, compliance en strategische doelstellingen. Met jouw helikopterview, communicatieve kracht en visie zorg je ervoor dat Quality Control een strategische partner is binnen de organisatie — en een sleutelelement in het succes van onze producten en processen.
- Vertalen van de bedrijfsstrategie naar een duidelijke kwaliteitsroadmap voor QC.
- Creëren van een cultuur waarin kwaliteit, compliance en veiligheid integraal onderdeel zijn van elke beslissing.
- Fungeren als strategisch aanspreekpunt voor interne en externe stakeholders op het gebied van kwaliteitsvraagstukken met betrekking tot Quality Control.
- Sturen op KPI’s met focus op lange termijn waardecreatie en duurzame procesoptimalisatie.
- Ontwikkelen van leiderschap en expertise binnen het QC-team.
- Identificeren van trends, risico’s en kansen, en proactief initiëren van verbeter- en innovatieprojecten.
- Deze functie heeft een sleutelpositie binnen de belangrijke strategische pijlers van contract manufacturing en interne product development.
Profiel
Match jij met de gevraagde opleiding en ervaring?
- Master diploma in farmacie, industrieel/ bio-ingenieur, (bio)chemie, of gelijkaardig.
- Minimaal 5 jaar aantoonbare leidinggevende ervaring binnen een labo, liefst in de farmaceutische sector.
- Begeleiden van nationale en internationale audits.
- Ervaring met Continuous Improvementprojecten en projectmanagement.
Bezit jij deze talenten?
- Je inspireert en motiveert je team met duidelijke communicatie en sterke organisatorische vaardigheden, en je weet je leiderschap in te zetten om mensen én processen naar een hoger niveau te tillen.
- Je schakelt vlot tussen verschillende taken en prioriteiten, en combineert je flexibiliteit met een gestructureerde, projectmatige aanpak die resultaten oplevert.
- Je werkt met een positieve, pragmatische instelling en hebt een uitgesproken can-do-mentaliteit, waardoor je obstakels ombuigt naar kansen.
- Je waarborgt de hoogste kwaliteitsnormen door nauwkeurig, ordelijk en betrouwbaar te werken en door kwaliteitsprocessen in het lab te bewaken en te verbeteren.
- Je blijft kalm en doelgericht onder druk, ook wanneer deadlines of onverwachte situaties om snelle beslissingen vragen.
- Je beschikt over sterke digitale vaardigheden; ervaring met SAP, statistische analysetools en Quality Control-software is een duidelijke troef.
- Je communiceert vlot in zowel Nederlands als Engels, mondeling én schriftelijk, waardoor je effectief samenwerkt met diverse interne en externe partners.
- NB Je bent niet allergisch aan penicillines of penicilline derivaten
Aanbod
Wij bieden een uitermate boeiende en gevarieerde functie in een gedreven en enthousiast team bij een solide onderneming. Er zijn veel mogelijkheden om je verder te ontwikkelen wanneer je zin voor initiatief en zelfontplooiing toont. Je kan rekenen op een competitief loon, aangevuld met extralegale voordelen zoals bedrijfswagen, laptop, GSM, eco-cheques, maaltijdcheques, hospitalisatie- en groepsverzekering, fietsleaseregeling. Om een goede work-lifebalance te bevorderen werken we met glijdende werktijden en heb je 35 verlofdagen per jaar.
Interesse in de functie van QC Manager? Stuur ons dan je CV en motivatie via
Team Leader QA/QC (Quality Assurance/Quality Control)
Publié il y a 3 jours
Emploi consulté
Description De L'emploi
Team Leader QA/QC (Quality Assurance & Quality Control)
Location: Belgium
VERDON is an EPC Contractor, key player in the construction of industrial facilities, combining traditional know-how (steel, welding, piping, boiler making) with digital innovation in all Value Chain.
For over 45 years, the company has stood out for its commitment to sustainable re-industrialisation.
With operations in Belgium and Europe, it offers comprehensive engineering, construction and maintenance solutions. As an integrator, it links design offices to on-site construction, while placing People, Technology and Artificial Intelligence (AI) at the heart of its projects.
Are you passionate about quality and teamwork? Join us as a Team Leader QA/QC and play a vital role in supervising and coaching a dynamic QA/QC team, ensuring compliance with industry regulations and our clients' high standards. This role offers an exciting opportunity to drive quality processes, foster continuous improvement, and lead a talented team.
Your Main Responsibilities
- Lead and Inspire: Organize and oversee a team of approximately 10 QA/QC Inspectors, operating both in our workshop and on project sites. Promote effective communication, teamwork, and collaboration within the team. Conduct periodic evaluations and partner with HR to organize quality awareness training for other teams across the company.
- Implement Quality Control Processes: Develop, execute, and maintain robust quality control procedures to ensure compliance with regulations and client specifications. These processes will cover activities from supplier management to product commissioning. Ensure that procedures are easily accessible using modern digital tools such as SharePoint or production ERP systems. Maintain and enhance company certifications.
- Oversee Testing Activities: Supervise the planning and execution of functional, performance, and safety tests, ensuring thorough documentation of results. Use digital tools to keep stakeholders informed of project progress.
- Drive Continuous Improvement: Identify opportunities to improve QA/QC processes and methodologies. Implement initiatives to enhance efficiency and product quality.
- Train and Develop the Team: Provide ongoing training to team members on new methodologies, tools, and technologies. Play an active role in team evaluations and professional development. Collaborate with HR to organize quality awareness sessions for other teams.
- Reporting and Documentation: Prepare regular reports on team performance, test results, and progress. Ensure comprehensive documentation of quality control processes.
What You Bring
- Proven experience as a QA/QC Engineer, including Team Leadership experience.
- In-depth knowledge of quality control methodologies, industry standards, and best practices.
- Strong technical skills in testing and tracking tools, as well as modern digital systems (e.g., SharePoint, ERP).
- Excellent communication and team management abilities, with a passion for coaching and fostering collaboration.
- A drive to unite team members around quality concepts and promote a culture of innovation and continuous improvement.
- Demonstrated problem-solving skills and the ability to make well-considered decisions in collaboration with project stakeholders.
- Mother tongue: French. Fluent in English.
Why Join Us?
- Be at the heart of quality initiatives, driving impactful projects in a thriving industry.
- Contribute to a culture of innovation and continuous growth in a supportive and collaborative work environment.
- Play a pivotal role in inspiring and shaping a team committed to high standards and professional development.
Are you the candidate we are looking for ?
Join us to shape the future together !
If you’re ready for this exciting Team Leader QA/QC challenge, send us your application now.
We’re eager to work with talent like you to elevate our company to new heights !
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À propos du dernier Quality control Emplois dans Belgique !
Lead Product Quality & Management System Coordinator
Publié il y a 4 jours
Emploi consulté
Description De L'emploi
Met meer dan 200 verwerkende bedrijven op vijf continenten en verkoop- en distributiekantoren in de hele wereld is Darling Ingredients, oorspronkelijk opgericht in 1882 als "Ira C. Darling & Company" in Chicago, een wereldwijde leider in het creëren van duurzame food-, feed- en fuel-ingrediënten uit organische voedingsstoffen.
Darling Ingredients International is een internationaal bedrijf die specifieke organische reststromen en dierlijke bijproducten op een innovatieve en duurzame manier verwerkt naar producten die bijdragen aan humane gezondheid, voeding, dierenvoeding en bio-energie. Vanuit het hart van de circulaire economie biedt het bedrijf producten en diensten aan voor een duurzamere planeet.
Om het kwaliteitsbeleid bij Darling Rendering & Specialties België (Rendac, Sonac & Ecoson) verder uit te bouwen zoeken we een enthousiaste (M/V)
Lead Product Quality & Management System Coordinator
Als Lead Product Quality & Management System Coordinator sta je in voor de coördinatie en opvolging van het proces quality control en quality assurance ten einde de kwaliteit en veiligheid van onze producten en processen te verbeteren en te verzekeren.
Je hebt hierbij de volgende taken:
- Als Lead QC/labo, Quality Assurance en management systeem coördinator zorg je ervoor dat de interne en externe processen continu geoptimaliseerd worden en dat kwaliteitsproblemen op een gestructureerde en doeltreffende manier worden aangepakt.
- Dankzij jouw coördinerend talent en technische expertise til je de eindproducten en dienstverlening naar een hoger niveau.
- Je coacht samen met uw team de operationele verantwoordelijken zodanig dat zij het nodige leiderschap kunnen aan de dag leggen om het kkwaliteitsbewustzijn op de werkvloer en het continu verbeteringsproces op de werkvloer te verhogen
- Je bent samen met uw team verantwoordelijk voor het onderhouden van het HACCP systeem en volgt de efficiëntie van nabij op;
- Je begeleidt, motiveert en versterkt het kwaliteitsteam. Dat team bestaat uit een 10-tal direct reports: laboranten, QC-coördinatoren, QA-coördinatoren, ingangscontrole ruwe grondstoffen, kwaliteitsmedewerkers.
- Je vertaalt de kwaliteitsstrategie en -beleid naar de operationele realiteit en bewaakt dat de verschillende managementsystemen (ISO 9001, ISO 14001 en HACCP) gerespecteerd en gecertificeerd blijven.
- Jet trekt belangrijke verbeterprojecten. Je blijft zoeken met het Q-team naar verdere procesverbeteringen om de productkwaliteit en efficiëntie te verhogen.
- Ook het begeleiden en managen van de interne en externe audits behoren tot jouw takenpakket: je voert zelf de nodige audits uit, maakt auditrapporten op en implementeert met de betrokken verantwoordelijken de nodige acties in de praktijk
- Samen met de Sheq manager optimaliseer je kwaliteitsnormen, methodes en procedures op in het kader van het kwaliteitssysteem en zorgt zo voor gestructureerde werkwijzen (focus proces denken en implementeren van proceskaarten/turtles). Focus op het ontwikkelen van een gestructureerd managementsysteem. Als management systeem coördinator faciliteer je de proceskaarten horende bij de high level processen binnen de organisatie. Je helpt de sheq manager om het proces denken binnen de organisatie verder vorm te geven.
- Je volgt kwaliteitsindicatoren en objectieven op en zorgt voor de rapportering naar de verschillende diensten;
- Je bent een coach voor uw team inzake kwaliteit en zorgt voor de nodige kwaliteitsopleidingen;
- Je staat in voor het beheer van kwaliteitssoftware ( JDE, SOL, SharePoint,.) en garandeert traceerbaarheid door jaarlijkse recall test, trainingen,.
- Tot slot bewaak en evalueer je mee de kwaliteitsprestaties van de leveranciers
- Je rapporteert aan de Sheq manager
Gezochte profiel
- Je bezit als master een technische en/of wetenschappelijke opleiding.
- Je bent gepassioneerd en gedreven!
- Je bent een teamplayer en werkt nauw samen met de sheq manager.
- Idealiter bouwde je als Quality Coördinator minimum 8 jaar relevante ervaring op in een industriële omgeving of heb je consultancy ervaring in het kwaliteitsgebeuren
- Je neemt graag initiatief, hebt een pragmatische, no nonsens aanpak en beschikt over een gezonde dosis creativiteit om problemen en nieuwe uitdagingen aan te pakken.
- Je kan deelnemen aan Root Cause Analysis onderzoeken en je biedt werkbare oplossingen voor de organisatie aan.
- Je bent administratief nauwkeurig, nauwgezet en je hebt oog voor detail.
- Je kan omgaan met deadlines en weet gericht prioriteiten te stellen.
- Naast jouw technische skills heb je ook de nodige people skills om je team en collega’s te begeleiden. Je communiceert vlot(ook in het Engels en Frans). Samenwerken doe je van nature: door je inzicht, empathie en aanpak kan je de interne stakeholders (vnl. productie) gemakkelijk meekrijgen.
- Kennis en ervaring in een multinationale of kwaliteit gedreven organisatie is een pluspunt.
- Ervaring met managementsystemen (kwaliteit en milieu) is een pluspunt.
- Je houdt het overzicht, kan vanuit een helikopter het kwaliteitsgebeuren benaderen(vanuit je bachelor of master denkniveau) en in details duiken wanneer nodig.
Gevarieerde functie in een internationaal, stabiel bedrijf
- Je komt terecht in een bedrijf dat deel uitmaakt van een internationale groep die veel belang hecht aan innovatie, investeert in groei van mensen en systemen en waar je de kans krijgt om samen met en binnen het bedrijf te groeien.
- Je rapporteert aan de SHEQ-manager en je stuurt mee een aantal collega’s aan in het kwaliteitsdepartement.
- Je maakt deel uit van het Belgisch SHEQ team waar je met je samen met je collega’s milieu, kwaliteit en veiligheid het SHEQ beleid van de organisatie uitbouwt.
- Je kan samenwerken met gedreven collega’s en met een management dat vlotte communicatie en het uitwisselen van ideeën voorop stelt.
- Je krijgt de ruimte om kwaliteitsbeleid verder te ontwikkelen en vorm te geven, en zo concrete resultaten te boeken in samenspraak met de sheq manager
- Een aantrekkelijk salaris met interessante extralegale voordelen wachten op je.
Senior Director, Quality Risk Management & External Engagement (Belgium, Ireland, Netherlands)

Hier
Emploi consulté
Description De L'emploi
Finance
**Job Sub** **Function:**
Risk Management
**Job Category:**
People Leader
**All Job Posting Locations:**
Beerse, Antwerp, Belgium, Leiden, South Holland, Netherlands, Ringaskiddy, Cork, Ireland
**Job Description:**
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).
+ USA (Raritan, Titusville, New Brunswick, Horsham) Req #: R-029351
+ Belgium (Beerse) Req #: R-029481
+ Switzerland (Schaffhausen, Basel) Req #: R-029469
+ Ireland (Cork) Req #: R-029481
+ Netherlands (Leiden) Req #: R-029481
**Position Summary**
The Senior Director, Quality Risk Management & External Engagement has oversight for the Regulatory Intelligence Programs in Clinical and Commercial Manufacturing (GxP, GMP, cGMP), Risk Management and Proactive Quality Planning functions for Innovative Medicine Quality & Compliance. This position is critical to the strategic design and implementation of an effective and proactive Risk Management & Regulatory Intelligence framework to optimally prepare and support the Innovative Medicine Quality & Compliance organization while enabling proactive alignment with emerging industry trends.
**Key Responsibilities:**
+ Provide expert guidance on GxP compliance before, during, and after regulatory inspections, partnering with key stakeholders such as Regulatory Affairs and Compliance to facilitate effective communication with Health Authorities.
+ Conduct oversight activities across business units by applying risk-based methodologies to various risk types, including Health Authority Inspections, Audits, Compliance projects, and quality initiatives.
+ Oversee end-to-end risk management processes, ensuring comprehensive risk assessments, effective mitigation strategies, and continuous monitoring are implemented across the organization. Additionally, ensure that the organization possesses the necessary capabilities to conduct robust risk assessments.
+ Integrate the Enterprise Risk Management (ERM) Framework through Predictive Risk Monitoring efforts within the R&D Quality team, establishing foundational risk governance.
+ Collaborate effectively to facilitate the deployment of compliance improvement initiatives and programs, including tracking the performance of remediation efforts and addressing associated risks.
+ Coordinate independent confirmation and verification assessments, preparing a consolidated and actionable overview of risks related to remediation initiatives.
+ Build and lead a dedicated team that analyzes external industry trends and inspection outcomes to identify focus areas for improvement.
+ Actively monitor and evaluate external industry trends, regulatory developments, and best practices, using this information to inform strategic decision-making across the business.
+ Develop initiatives to integrate these insights into the Quality Management System (QMS) and operational procedures, ensuring alignment with industry standards and proactive risk mitigation.
+ Ensure that relevant information is proactively communicated to business partners and seamlessly integrated into audit and inspection readiness programs.
+ Identify and evaluate opportunities for process improvement based on compliance and risk monitoring outcomes.
+ Develop a comprehensive framework for evaluating key inputs while establishing an end-to-end governance process for assessing compliance and risk.
+ Reinforce the importance of compliance and quality within the organization, ensuring the effective implementation of compliance strategies and our ability to detect and quantify risk appropriately.
+ Serve as a key participant in industry forums and conferences to gain insights into emerging trends and developments within the industry, which will inform strategic initiatives and ensure that the organization remains aligned with best practices and competitive standards.
**Required Minimum Education** : BS degree required. Masters or advanced degree in a scientific field (Life Sciences, Pharmacy, Engineering) desirable.
**Required Years of Related Experience:**
+ Requires at least 15 years of experience with 5 plus years' experience and demonstrated leadership in a quality function working on complex and significant compliance topics.
+ Minimum 5 years of proven people leader experience
+ Must have comprehensive knowledge of GxP, GMP, cGMP and IT compliance regulations and guidelines, with expert knowledge on US and EMEA Regulations
+ Requires knowledge of latest auditing, investigation, and remediation techniques as well as leadership experience with inspections.
+ Demonstrated effective influencing, interpersonal, written, and verbal communications skills as well as a proven track record of sustaining compliance in complex organizations.
+ Regulatory Authority experience is desirable
+ Experience with Regulatory Authorities is a significant asset
**Required Knowledge, Skills and Abilities** :
+ Strong Quality and Compliance background with a deep understanding of Global GxP, GMP, cGMP requirements and the systems used to deploy them.
+ Experience in the identification and management of risks, including the development of risk-based remediation strategies and reporting risks/status in a concise manner.
+ Strong influencing and negotiation skills.
+ Excellent written and oral communication skills.
+ Strong interpersonal skills, including ability to communicate with individuals and groups at all levels. Experience establishing relationships with other functions within the company.
+ Strong decision making and analysis skills.
+ Demonstrated conflict and change management skills.
+ Strategic Thinking - ability to view bigger picture and translate complex issues into solution-based answers that drive real and sustainable change.
+ Proven hands-on experience with quality risk management methodologies
+ Strong computer skills with Quality Systems.
+ Sense of Urgency - ability to lead and deliver on multiple projects in a timely manner.
+ Teamwork and Collaboration - ability to lead, manage and participate on teams with shared responsibility for decisions and results.
+ Confidentiality - ability to maintain confidentiality as appropriate.
+ Systems Thinker - understanding how process / actions interact and influence other areas within a whole
**Required Years of Related Experience:**
+ Requires at least 15 years of experience with 5 plus years' experience and demonstrated leadership in a quality function working on complex and significant compliance topics.
+ Minimum 5 years of proven people leader experience
+ Must have comprehensive knowledge of GxP, GMP, cGMP and IT compliance regulations and guidelines, with expert knowledge on US and EMEA Regulations
+ Requires knowledge of latest auditing, investigation, and remediation techniques as well as leadership experience with inspections.
+ Demonstrated effective influencing, interpersonal, written, and verbal communications skills as well as a proven track record of sustaining compliance in complex organizations.
+ Regulatory Authority experience is desirable
+ Experience with Regulatory Authorities is a significant asset
**Required Knowledge, Skills and Abilities** :
+ Strong Quality and Compliance background with a deep understanding of Global GxP, GMP, cGMP requirements and the systems used to deploy them.
+ Experience in the identification and management of risks, including the development of risk-based remediation strategies and reporting risks/status in a concise manner.
+ Strong influencing and negotiation skills.
+ Excellent written and oral communication skills.
+ Strong interpersonal skills, including ability to communicate with individuals and groups at all levels. Experience establishing relationships with other functions within the company.
+ Strong decision making and analysis skills.
+ Demonstrated conflict and change management skills.
+ Strategic Thinking - ability to view bigger picture and translate complex issues into solution-based answers that drive real and sustainable change.
+ Proven hands-on experience with quality risk management methodologies
+ Strong computer skills with Quality Systems.
+ Sense of Urgency - ability to lead and deliver on multiple projects in a timely manner.
+ Teamwork and Collaboration - ability to lead, manage and participate on teams with shared responsibility for decisions and results.
+ Confidentiality - ability to maintain confidentiality as appropriate.
+ Systems Thinker - understanding how process / actions interact and influence other areas within a whole.
+ Travel requirements: approximately 20-30% global travel will be required.
This position is located in the US or EU and can be based at any Innovative Medicine Supply Chain site.
Quality Assurance
Publié il y a 3 jours
Emploi consulté
Description De L'emploi
Oxford Global Resources is partnering with a company in the healthcare and pharmaceutical industry for an experienced QA.
In this role you act according to the Quality Assurance (QA) vision, strategy and standards for the integrated central, Quality Operations group for all product categories: medicinal products, medical devices, food supplements, cosmetics and biocides.
Key Responsibilities:
- QA representative within the cosmetic category and be responsible for all QA matters associated with these:
- Assist with due diligence and integration of new product developments / new product introductions
- Investigate quality incidents, deviations and complaints, identify and follow-up CAPA’s and improvement plans together with third-parties (contract manufacturers, logistic service providers, distributors), to coordinate Change control process and follow-up implementation of changes
- Coordinate rework of cosmetic products and ensure correct release of reworked products
- Maintain correct product identification and traceability throughout the supply chain
- Having a key role in reporting and investigating critical non-conformities and identifying opportunities for improvement
- Assisting in performing internal QA and customer audits as appropriate
- Ensuring ongoing inspection readiness in your area of responsibilities
What We’re Looking For:
- Master’s degree in pharmaceutical sciences, engineering, biochemistry, chemistry or equivalent through experience
- Minimum 3 years in Quality/Technical support within a Healthcare Company
- Experience with project related work and working with cross-functional teams
- Fluent English skills, other languages are an asset
- Experience with cosmetic products is a plus
If you are passionate about clinical research and ready for your next challenge in a dynamic international environment, we’d love to hear from you!