Quality Manager Design & Qualification (all genders) - limited until 30.06.2028
Core
Ensure Commissioning and Qualification (C&Q) activities for a new insulin drug substance facility, covering design, utilities, equipment, and computerized systems.
Role type
Senior Quality Manager (Design & Qualification)
Builds
A fully automated, sustainable biologics site for insulin manufacturing.
Domain
Biopharma / Insulin Manufacturing / Facility Construction
Required skills
Quality System Management, Process Validation Lifecycle, Quality by Design, cGMP compliance, Risk Management, Supplier Qualification, Protocol Development, Regulatory Knowledge (FDA/GxP)
Preferred skills
MSc or PhD, German language knowledge, French language knowledge
Technologies
Computerized Systems, Validation Master Plans, FAT/SAT protocols
Responsibilities
Oversee C&Q activities for facilities, utilities, and equipment; Develop and implement validation strategies; Act as quality oversight for supplier qualification; Prepare and execute validation protocols and reports; Mentor team members on quality best practices.
Seniority
Senior, hands-on IC with leadership responsibilities