QA Manager, External Supply Quality

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Job Description

QA 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 QA Manager, External Supply Quality in Amgen Singapore Manufacturing.

Live
What you will do
In this position, you’ll lead quality oversight for 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 will require occasional travel to contract manufacturing locations located in China, Japan, Singapore, and India.  Candidates located in other JAPAC regions may be considered based on qualifications. 

In this influential role, you will:

• Drive proactive quality management of suppliers, ensuring compliance with global GMP standards and Amgen’s high expectations.
• Act as the quality lead for supplier relationships, ensuring performance through robust monitoring, technical site visits, and continuous improvement.
• Review and approve quality documentation, including master batch records, deviations, CAPAs, product complaints, and change controls, with a sharp eye for risk and compliance.
• Provide quality oversight and approval steps for new product introductions, tech transfers, analytical and method qualifications and validations, and process qualification activities at the contract manufacturing site.
• Perform tactical batch disposition activities in support of lot release.
• Negotiate Quality Agreement terms and conditions and ensure adherence.
• Perform supplier audits for key manufacturers within the JAPAC region.
• 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 occasional travel and onsite engagement with contract manufacturing sites.

Win
What we expect of you

• Doctorate degree OR
• Master’s degree and 2 years of directly related experience OR
• Bachelor’s degree and 4 years of directly related experience OR
• Diploma and 8 years of directly related experience in 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.
• Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing).
• Confident communicator who can build relationships across technical and cultural boundaries.
• Track record of driving change, improving systems, and mentoring/coaching others.
• Skilled in using risk based decision-making approaches.
• Experience with regulatory activities and variation management

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

Thrive

What you can expect of us

As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth 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

Apply now

for a career that defies imagination

In our quest to serve patients above all else, 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 and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.

We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.