Quality Assurance Senior Manager (External Supply Quality) at Amigen

Singapore, , Singapore -

Full Time

Start Date

Immediate

Expiry Date

30 Apr, 26

Salary

0.0

Posted On

30 Jan, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Management, GMP Compliance, Supplier Relationships, Technical Site Visits, Continuous Improvement, Quality Oversight, Risk Management, Regulatory Activities, Analytical Testing, Batch Disposition, Change Controls, Audits, Investigations, Communication, Collaboration, Mentoring

Industry

Biotechnology Research

Description

Career Category Quality Job Description Quality Assurance Senior 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 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? In this position, you’ll lead quality oversight for Amgen Contract Manufacturing locations in India. 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 frequent travel to contract manufacturing locations in 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. 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 occasional 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 We are looking for a quality professional who thrives in a dynamic, matrixed environment and is passionate about driving performance and fostering collaboration. Strong background in GMP compliance, with a focus on external manufacturing or materials management. Significant 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. Proven ability to lead audits, manage complex investigations, and influence quality improvements. 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 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 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. 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. . Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen

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Responsibilities

Lead quality oversight for Amgen Contract Manufacturing locations in India, ensuring compliance with global GMP standards. Act as the quality lead for supplier relationships and drive proactive quality management.