Gmp Quality Manager

il y a 2 semaines

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

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