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Quality Assurance Senior Manager, External Supply Quality

Singapore, Singapore · Job Posted July 03, 2026
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Job Description

Quality Assurance Senior Manager (External Supply Quality) at Amgen Singapore Manufacturing. Lead quality oversight for Amgen Contract Manufacturing locations in India. This role will be located in Singapore and require occasional travel to contract manufacturing locations in India. A strong background in synthetics or peptide manufacturing is preferred for this role.

Job Responsibility

  • Act as the quality lead for supplier relationships, ensuring performance through robust monitoring, technical site visits, and continuous improvement
  • Drive proactive quality management of suppliers, ensuring compliance with global GMP standards and Amgen’s high expectations
  • Provide quality oversight of new product introductions, tech transfers, and process qualification activities at the contract manufacturing site
  • Review and approve quality documentation, including master batch records, deviations, CAPAs, product complaints, and change controls, with a sharp eye for risk and compliance
  • Perform tactical batch disposition activities in support of lot release
  • Negotiate Quality Agreement terms and conditions and ensure adherence
  • Act as a key quality partner to manufacturing, supply chain, process development, and other Amgen internal functions
  • Take the lead in cross-functional initiatives and continuous improvement projects to improve regional operations and daily tasks
  • Ensure inspection readiness for our contract manufacturing sites and internal Amgen records
  • Support management of audit/inspection commitments to completion
  • Represent Amgen at product-specific regulatory inspections of the contract manufacturing site
  • As needed, perform person in plant responsibilities during Amgen manufacturing campaigns or to support key process steps at the contract manufacturer
  • Role will require travel and onsite engagement with contract manufacturing sites

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 commercial manufacturing facilities
  • Confident communicator who can build relationships across technical and cultural boundaries
  • Track record of driving change, improving systems, and mentoring others within Quality
  • Skilled in using risk based decision-making approaches
  • Experience with regulatory activities and variation management
  • Proven ability to lead audits, manage complex investigations, and influence quality improvements
  • Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing)

Nice to have

Technical experience with synthetics or peptide manufacturing is a strong plus

What we offer

  • 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

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