Quality Assurance Senior Manager, External Supply Quality

Quality Assurance Senior Manager(External Supply Quality)

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION?

Amgen is one of theworld’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 anddeveloped innovative human therapeutics, but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies tomedical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a QualityAssurance Senior 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? Inthis position, you’ll lead quality oversight for Amgen Contract Manufacturinglocations in India.  You will have regional responsibilities acrossmanufacturing sites and operate at the intersection of quality, innovation, andglobal collaboration to ensure reliable and quality supply of ourproducts.  This role will be located in Singapore and require occasionaltravel to contract manufacturing locations in India.   A strongbackground in synthetics or peptide manufacturing is preferred for this role.

In this influential role, you will:

• 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.

Win

What we expect of you

Basic Qualifications

• 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. Technical experience with synthetics or peptide manufacturing is a strong plus.
• 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).

Thrive

What you can expect of us

As we work to develop treatments that takecare of others, so we work to care for our teammates’ professional and personalgrowth and well-being.

• 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

Your selection for this role will be subjectto fulfilling the medical requirements of this job scope. If so, you will beinformed of the medical check(s) that you may need to undergo. All medicalrelated expenses incurred from this medical check shall be borne by thecompany.

Apply now

for a career that defiesimagination

In our quest to serve patients above allelse, Amgen is the first to imagine, and the last to doubt. Join us.

careers.amgen.com

Equal Opportunity Statement

Amgen is an Equal Opportunity employer andwill consider you without regard to your race, color, religion, sex, sexualorientation, gender identity, national origin, protected veteran status, ordisability status.

We will ensure that individuals withdisabilities are provided a reasonable accommodation to participate in the jobapplication or interview process, to perform essential job functions, and toreceive other benefits and privileges of employment. Please contact us torequest an accommodation.