Quality Assurance Manager, External Supply Quality

Career Category

Quality

Job Description

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.

Experience with regulatory activities, variation management, and commercial product disposition requirements.

Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing).

Track record of driving change, improving systems, and mentoring others within Quality.

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

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.

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.

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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.

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