Product Quality Manufacturing and Testing Lead

Seeking a new challenge in quality management? Join a role where your GMP expertise supports high-quality drug development.

We are looking for an experienced professional to ensure quality oversight of outsourced GMP activities at CDMOs, including manufacturing, QC testing, and release of drug substances, drug products, and finished goods.

The role also involves implementing and maintaining a compliant GMP quality infrastructure, in close collaboration with internal business teams.

Your mission :

• Lead the quality activities related to the asset programs and CMOs assigned and maintain good relationship with the internal and external partners.
• Review deviation investigations, CAPA and change controls
• Review batch record documentation and support release of investigational Medicinal Product and commercial Product
• Review of qualification and validation protocol / reports
• Responsible for issuance quality agreements with external parties
• Support the further build-out of quality processes and systems and maintenance and continuous improvements of the QMS system.
• Ensure continuous improvements opportunities are identified and implemented with the partners and internally.
• Support the Global Internal Audit Program
• Support the Global External Audit Program through the execution of qualification audits and routine GMP audits as well as non-GxP vendor qualifications
• Proactively identify and track project critical path items ‐ identify risks, formulate and monitor corrective actions.

What about you :

Why join us :

Ready to be a part of this exciting project ? Apply now, we’re excited to meet you!