Related skills
quality assurance audits gmp capa cgmp📋 Description
- Coordinate QA requirements from partnerships with alliance teams
- Lead QA activities for onboarding new partners
- Develop scalable onboarding and QA integration frameworks
- Lead partner QA audits
- Develop Quality Agreement standards for in-licensing partnerships
- Review change controls, deviations, investigations, CAPAs for partner supply
🎯 Requirements
- Bachelor’s degree (BSc) or higher in a scientific discipline
- 10+ years in pharmaceutical manufacturing and quality functions
- Strong knowledge of global cGMP regulations and trends
- Experience in biopharma or pharma start-up environments
- Preference for hosting regulatory inspections and audits
- Ability to influence and collaborate across all organizational levels
- Experience working with external partners, alliances, or contract organizations
- Willingness to travel up to 15% annually
🎁 Benefits
- Equal Opportunity Employer
- Hybrid work arrangement
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