Quality Assurance Manager, External Supply Quality

Singapore Manufacturing - Tuas JOB ID: R-248608 LOCATION: Singapore Manufacturing - Tuas ; Singapore - Singapore WORK LOCATION TYPE: Flex Commuter / Hybrid DATE POSTED: Jul. 01, 2026 CATEGORY: Quality Quality Assurance Manager (External Supply Quality)

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of the world’s leading independent biotechnology companies. For over 4 decades, Amgen has pioneered biotechnology breakthroughs, to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Quality Assurance Manager (External Supply Quality) in Amgen Singapore Manufacturing.

Live

What you will do

Are you a strategic quality leader, ready to take on a high-impact role? In this position, you’ll be responsible for quality oversight for Internal Amgen Quality Records and external Amgen Contract Manufacturing locations in the JAPAC region. You will have regional responsibilities across manufacturing sites and operate at the intersection of quality, innovation, and global collaboration to ensure reliable and quality supply of our products. This role will be located in Singapore and require occasional travel to contract manufacturing locations.

In this influential role, you will:

• Review and approve quality documentation, including master batch records, deviations, CAPAs, product complaints, and change controls, with a sharp eye for risk and compliance.
• Act as a key quality partner to manufacturing, supply chain, process development, and other Amgen internal functions and build meaningful and trusting team relationships.
• Take the lead in cross-functional initiatives and continuous improvement projects to improve regional operations and daily tasks.
• Provide quality oversight and approval for analytical testing methods and analytical test transfers to contract manufacturing operations.
• Lead supplier audits on behalf of Amgen for suppliers located in the JAPAC region.
• As needed, perform person in plant responsibilities during Amgen manufacturing campaigns or to support key process steps at the contract manufacturer.
• Provide quality oversight of new product introductions, tech transfers, and process qualification activities at the contract manufacturing site.
• Drive proactive quality management of suppliers, ensuring compliance with global GMP standards and Amgen’s high expectations.
• 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.
• Negotiate Quality Agreement terms and conditions and ensure adherence.
• Perform tactical batch disposition activities in support of lot release.
• Role may require occasional travel and onsite engagement with contract manufacturing sites.

Win

What we expect of you

Basic Qualifications

• Doctorate degree OR
• Master’s degree and 2 years of Quality and Compliance experience OR
• Bachelor’s degree and 4 years of Quality and Compliance experience OR
• Diploma and 8 years of directly related experience
• Strong background in GMP compliance, ideally with a focus in manufacturing or materials management.
• Confident communicator who can build relationships across technical and cultural boundaries.
• Quality and/or Manufacturing experience at small and/or large molecule drug substance, drug product, and packaging manufacturing facilities.
• Proven ability to lead audits, manage complex investigations, and influence quality improvements.
• Skilled in using risk based decision-making approaches.