Quality Assurance Senior Manager, External Supply Quality
Amgen
Quality Assurance Senior Manager, External Supply Quality
Job Description
Career CategoryQualityJob DescriptionQuality Assurance Senior Manager (External Supply Quality)Amgen Singapore ManufacturingHOW 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.LiveWhat you will doAre 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 occasional travel to contract manufacturing locations in India. A strong background 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 releaseNegotiate 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.WinWhat we expect of youBasic QualificationsDoctorate degree and 2 years of Quality and Compliance experience ORMaster’s degree and 6 years of Quality and Compliance experience ORBachelor’s degree and/or 8 years of Quality and Compliance experienceStrong 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).ThriveWhat you can expect of usAs 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 organizationDiverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and actGenerous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefitsYour 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 nowfor a career that defies imaginationIn our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.careers.amgen.comEqual Opportunity StatementAmgen 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..
Locations
- Singapore Manufacturing - Tuas
- Singapore - Singapore
Skills Required
- GMP complianceintermediate
- syntheticsintermediate
- using risk based decision-making approachesintermediate
- regulatory activitiesintermediate
- analytical testing situationsintermediate
Required Qualifications
- Doctorate degree and 2 years of Quality and Compliance experience OR (experience, 2 years)
- Master’s degree and 6 years of Quality and Compliance experience OR (experience, 6 years)
- Bachelor’s degree and/or 8 years of Quality and Compliance experience (experience, 8 years)
- Strong background in GMP compliance, with a focus on external manufacturing or materials management. (experience)
- Significant Quality and/or Manufacturing experience at commercial manufacturing facilities. Technical experience with synthetics or peptide manufacturing is a strong plus. (experience)
- Confident communicator who can build relationships across technical and cultural boundaries. (experience)
- Track record of driving change, improving systems, and mentoring others within Quality. (experience)
- Skilled in using risk based decision-making approaches. (experience)
- Experience with regulatory activities and variation management. (experience)
- Proven ability to lead audits, manage complex investigations, and influence quality improvements. (experience)
- Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing). (experience)
- Doctorate degree and 2 years of Quality and Compliance experience OR (experience, 2 years)
- Master’s degree and 6 years of Quality and Compliance experience OR (experience, 6 years)
- Bachelor’s degree and/or 8 years of Quality and Compliance experience (experience, 8 years)
- Strong background in GMP compliance, with a focus on external manufacturing or materials management. (experience)
- Significant Quality and/or Manufacturing experience at commercial manufacturing facilities. Technical experience with synthetics or peptide manufacturing is a strong plus. (experience)
- Confident communicator who can build relationships across technical and cultural boundaries. (experience)
- Track record of driving change, improving systems, and mentoring others within Quality. (experience)
- Skilled in using risk based decision-making approaches. (experience)
- Experience with regulatory activities and variation management. (experience)
- Proven ability to lead audits, manage complex investigations, and influence quality improvements. (experience)
- Experience with analytical testing situations (e.g. method transfers, analytical qualifications, stability, lab investigations, in process testing, release testing). (experience)
Responsibilities
- 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.
- 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.
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