Gmp Quality Manager

il y a 3 jours

Gent, Belgique Argenx Temps plein

To further strengthen our Quality team, we are looking for an experienced and motivated GMP Quality Manager. The GMP Quality Manager will play a role in further build out of GMP quality infrastructure at argenx in close collaboration with internal business teams and will be responsible to ensure the quality oversight of CMO’s involved in manufacturing and analytical testing.

The position reports to the Product Quality Lead, development.

**Key Accountabilities and Responsibilities**:

- Support the further build-out of quality processes and systems.
- Provide strategic GMP guidance to third-party vendors and partners to ensure quality and compliance of argenx products.
- Conduct or supervision of quality assurance activities regarding, but not limited to:

- Review of product complaints
- review of deviation investigations and related corrective and preventive actions
- review of change controls and related effectiveness checks
- review batch record documentation and support release Product
- review of internal protocols, report and Certificates of Analysis
- support mock recall
- training
- In close collaboration with the manufacturing teams and GMP Quality Managers:

- review process qualification protocols and reports
- review test method validation protocols and reports
- review stability plans and reports
- review Specification documents and Certificates of Analysis
- support release of Product
- Monitoring of the performance of the analytical methods and vendors through metrics
- Review quality agreements with external parties.
- Contributes to internal and external audit planning and follow-up.
- Support the Global External Audit Program through the execution of qualification audits and routine GMP audits of argenx supply chain; Support HA inspection, pre-approval inspections and work with internal stakeholders and external parties to prepare for these inspections.
- Support follow-up of the above audits and inspections and ensure appropriate and timely CAPA implementation.
- The role may also support the QA team with additional ad hoc project support

**Desired Skills and Experiences**:

- 5y+ experience in a quality assurance role, dealing with biopharmaceuticals with experience in GMP/GDP and biological analytical methods.
- Experience with manufacturing and/or lab activities is a plus
- Experience with audits and experience with preparation of regulatory inspections (FDA, EMA, PMDA,) is a plus.
- In-depth knowledge of FDA and EU regulations and ICH Guidelines.
- Leadership and collaboration skills, including excellent verbal and written communication skills at all levels.
- Ability to work independently and to make decisions based on experience.
- Expected to be versatile and flexible and to independently manage projects and make sound decisions related to product quality issues.
- Strong technical mastery, analytical and investigation skills.
- Accurate in execution and reporting, quality-minded.
- Able to operate in a dynamic surrounding of a fast growing biotech company with challenging timelines.
- Able to work effectively together with both internal and external stakeholders.
- Fluent in English - our working language.

**Offer**:

- A competitive salary package with extensive benefits
- Front seat in the development of therapeutic antibodies
- A work environment in a human-sized, dynamic and rapidly growing biotech company
- Possibility to work remotely with limited travelling required

  • Quality Assurance Manager

    il y a 3 jours

    Gent, Belgique DeLaval Temps plein

    The Product Portfolio Milk Quality & Animal Health (PP MQAH) produces and distributes chemical products by, among others, the Chemicals Division in Drongen (Ghent). The Product Portfolio consists of udder hygiene products, hoof disinfectants and detergents used by dairy farmers around the world. We are currently looking for a **Quality Assurance Manager...

  • Sr. Manager Quality Systems

    il y a 2 jours

    Gent, Belgique Johnson & Johnson Temps plein

    Johnson & Johnson (J&J) is recruiting a Senior Manager Quality System & Engineering for the CAR-T hub in Europe. The position will be based in Beerse or Ghent 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...

  • Interim Quality Manager

    il y a 2 jours

    Gent, Belgique elekti. Temps plein

    **Interim Quality Manager.**: **De functie**: De functie gebonden verantwoordelijkheden zijn: - Implementeren, onderhouden en bijsturen van het kwaliteitszorgsysteem zodat wordt voldaan aan de normen voor ACS (voedselveiligheid), IFS en het intern bedrijfskwaliteitsniveau. - Verantwoordelijke voor de efficiënte werking van het eigen labo zodat de nodige...

  • Analyst Quality Assurance

    il y a 2 jours

    Gent, Belgique Johnson & Johnson Temps plein

    **Function** - Quality **Sub function** - Quality Assurance **Category** - Analyst, Quality Assurance (P4 - E24) **Location** - Gent / Belgium **Date posted** - Jun 05 2025 **Requisition number** - R-011348 **Work pattern** - Hybrid Work Description **Job Function**: Quality ** Job Sub Function**: Quality Assurance ** Job Category**: Professional ...

  • Expert Analyst Quality Assurance

    il y a 2 jours

    Gent, Belgique Johnson & Johnson Temps plein

    **Function** - Quality **Sub function** - Quality Assurance **Category** - Experienced Analyst, Quality Assurance (P5) **Location** - Gent / Belgium **Date posted** - Jun 05 2025 **Requisition number** - R-011349 **Work pattern** - Hybrid Work Description **Job Function**: Quality ** Job Sub Function**: Quality Assurance ** Job...

  • Quality Associate

    il y a 3 jours

    Gent, Belgique TMC Temps plein

    Belgium Life Sciences Ghent On-site Looking to drive continuous improvement and ensure quality standards in the pharmaceutical industry? Join us as Quality Associate! - About The Member Company - We are a global high-tech consultancy company with a team of entrepreneurial engineers, scientists, and digital experts from around the world. Together we form a...

  • Quality Associate

    il y a 3 jours

    Gent, Belgique TMC Temps plein

    Belgium Life Sciences Ghent Looking to drive continuous improvement and ensure quality standards in the pharmaceutical industry? Join us as Quality Associate! - About The Member Company - We are a global high-tech consultancy company with a team of entrepreneurial engineers, scientists, and digital experts from around the world. Together we form a...

  • Compliance Manager

    il y a 2 jours

    Gent, Belgique Johnson & Johnson Temps plein

    **Function** - Legal & Compliance **Sub function** - Enterprise Compliance **Category** - Manager, Enterprise Compliance (P7) **Location** - Gent / Beerse / Belgium **Date posted** - Jun 06 2025 **Requisition number** - R-017272 **Work pattern** - Hybrid Work Description **Job Function**: Legal & Compliance ** Job Sub Function**: Enterprise...

  • Compliance Manager

    il y a 2 jours

    Gent, Belgique Johnson & Johnson Temps plein

    For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo. We know that the success of our business depends on having the best talent in a workforce that reflects the...

  • Quality Assurance Associate

    il y a 2 jours

    Gent, Belgique Perrigo Temps plein

    At Perrigo, we are driven by our mission to **_Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All_**. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing **_The Best Self-Care for Everyone_**, we...