Quality Assurance Senior Manager, External Supply Quality
Amgen · Tuas +1 more
The apply link worked recently (not employer-confirmed).
Role summary
Amgen seeks a Quality Assurance Senior Manager to oversee external supply quality for contract manufacturing operations in India, based in Singapore. The role involves leading supplier quality management, ensuring GMP compliance, managing documentation and regulatory inspections, and supporting product transfers and process qualifications. Candidates require advanced relevant qualifications plus substantial quality or manufacturing experience, with synthetic or peptide manufacturing background preferred.
What they're looking for
- Doctorate plus 2 years quality/compliance experience, or Master's plus 6 years, or Bachelor's plus 8 years
- Strong GMP compliance background with external manufacturing or materials management focus
- Significant quality and manufacturing experience at commercial facilities
- Technical experience in synthetics or peptide manufacturing preferred
- Confident communicator able to build relationships across technical and cultural boundaries
- Track record driving change, improving systems, and mentoring quality personnel
- Skilled in risk-based decision-making and regulatory activities/variation management
What you'll be doing
- Lead quality oversight for Amgen contract manufacturing locations in India with regional responsibilities
- Monitor supplier performance through technical site visits and drive proactive compliance with GMP standards
- Provide quality oversight of new product introductions, tech transfers, and process qualifications
- Review and approve quality documentation including batch records, deviations, CAPAs, and change controls
- Support audit and inspection readiness at contract manufacturing sites and represent Amgen at regulatory inspections
Privacy & handoff
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