Quality Manager IFF (all genders)
Core
Ensure quality culture, GMP compliance, and execution of qualification/validation strategies for a new automated insulin drug substance facility in Frankfurt.
Role type
Senior Quality Manager (Project)
Builds
A fully automated biologics site for insulin production
Domain
Biopharmaceuticals / Insulin Manufacturing
Required skills
Quality System Management, GxP compliance, Validation strategies, Risk Management, Scientific writing, Regulatory knowledge (FDA/Health Canada), German language proficiency, English language proficiency
Preferred skills
MSc in Science/Pharmacy, Biologic product license application experience, Automation knowledge, Strategic planning
Technologies
QMS systems, Validation tools (IQ/OQ/PQ)
Responsibilities
Ensure GMP compliance across project phases, Develop and update Global Quality Documentation and procedures, Support qualification and validation protocols, Mentor project team members on quality behaviors, Support regulatory inspections (FDA, Health Canada), Manage maintenance master data migration
Seniority
Senior, hands-on IC
