Base: €79,104.00 - €105,472; bonus/equity: not spe...
Gmp compliance expertise
Qualification and validation strategies
Quality system management
The role involves ensuring quality assurance activities are executed on time in accordance with project, local, and global requirements for a new automated insulin facility
Job Summary
The role involves ensuring quality assurance activities are executed on time in accordance with project, local, and global requirements for a new automated insulin facility.
Candidates will act as the primary Quality Subject Matter Expert, developing QMS measures and supporting qualification protocols like IQ, OQ, and PQ.
The position requires active engagement in compliance inspections including FDA, Health Canada, and internal audits while mentoring project teams on quality behaviors.
Matching Summary
The role involves ensuring quality assurance activities are executed on time in accordance with project, local, and global requirements for a new automated insulin facility.
Salary
Base: €79,104.00 - €105,472; Bonus/Equity: Not specified; Benefits: Eligible for company employee benefit programs
Skills & Requirements
Must-have
GMP compliance expertise
Qualification and validation strategies
Quality system management
Regulatory inspection support
Risk-based decision making
Nice-to-have
German language proficiency
Digital transformation experience
Cross-functional team leadership
Innovative thinking skills
Scientific writing abilities
Key Requirements
MSc Degree or Diploma in Science/Pharmacy
In-depth knowledge of biologic product license application process
Practical experience in Quality System Management within regulated industry