Senior Quality Assurance Manager, External Supply Quality
Amgen
full-time
Posted on:
Location Type: Hybrid
Location: Singapore • Singapore
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Job Level
About the role
- Lead quality oversight for Amgen Contract Manufacturing locations in India
- Drive proactive quality management of suppliers, ensuring compliance with global GMP standards
- Act as the quality lead for supplier relationships
- Provide quality oversight of new product introductions, tech transfers, and process qualification activities
- Review and approve quality documentation, including master batch records, deviations, CAPAs, product complaints, and change controls
- Perform tactical batch disposition activities in support of lot release
- Negotiate Quality Agreement terms and conditions
- Act as a key quality partner to manufacturing, supply chain, process development, and other Amgen internal functions
- Ensure inspection readiness for our contract manufacturing sites and internal Amgen records
- Represent Amgen at product-specific regulatory inspections of the contract manufacturing site
Requirements
- Doctorate degree and 2 years of Quality and Compliance experience OR Master's degree and 6 years of Quality and Compliance experience OR Bachelor's degree and/or 8 years of Quality and Compliance experience
- Strong background in GMP compliance, with a focus on external manufacturing or materials management
- Significant Quality and/or Manufacturing experience at small and/or large molecule drug substance or drug product manufacturing facilities
- Technical experience with synthetics/small molecules a strong plus
- Proven ability to lead audits, manage complex investigations, and influence quality improvements
- Experience with regulatory activities and variation management
- Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing)
Benefits
- Vast opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills & Tools
GMP compliancequality managementquality oversightbatch dispositionregulatory activitiesanalytical testingmethod transfersprocess qualificationCAPAsdeviations
Soft Skills
leadershipnegotiationinfluencecommunicationcollaborationproblem-solvingaudit managementinvestigation managementquality improvementrelationship management
Certifications
Doctorate degreeMaster's degreeBachelor's degree