Manager QA - Nights
Amgen
August 21, 2026
On-site
West Greenwich, RI
Operations
Manager QA - Nights
What You Will Do
- Hire, train, develop, and manage Quality Assurance professionals to support GMP Manufacturing and manage change compliantly.
- Oversee Night shift Quality Assurance teams (M-F 6pm–2:30am).
- Independently determine approach to managing daily operations (guided by policies/management guidance).
- Develop/provide procedures and standards; interpret and execute standards affecting work activities.
- Develop and communicate goals/objectives to staff and key partners; monitor performance and coordinate improvements via OPEX.
- Represent Quality Assurance on incident triage teams; provide guidance/technical leadership.
- Partner with management levels to resolve issues, establish direction, obtain resources, and drive change.
- Review/approve operational and manufacturing procedures; approve process validation protocols/reports, environmental characterization reports, and change control documents.
- Approve non-conformances; represent QA on project teams; approve change-over completion controls.
- Lead investigations, plant, and site audits.
Basic Qualifications (choose one)
- High school diploma/GED + 12 years Quality or Manufacturing experience OR
- Associate’s + 10 years OR
- Bachelor’s + 5 years OR
- Master’s + 3 years OR
- Doctorate.
- Plus experience managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.
Preferred Qualifications
- Bachelor’s in Life Sciences/Engineering or related; 6+ years biotech/pharma QA (or combined QA/manufacturing); 2+ years supervisory/management.
- Experience with manufacturing, investigations, CAPA, product release, validation, and/or change control; biotech multi-product regulations/standards.
- Knowledge of monoclonal antibody manufacturing; risk-based decision-making; clear communication and collaboration.
Total Rewards Plan (benefits listed)
- Health/welfare, retirement savings contributions, life/disability, flexible spending, discretionary bonus (or sales incentive), stock-based long-term incentives, time-off plans; flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com; no application deadline (accepted until sufficient candidates or selection).
What You Will Do
- Hire, train, develop, and manage Quality Assurance professionals to support GMP Manufacturing and manage change compliantly.
- Oversee Night shift Quality Assurance teams (M-F 6pm–2:30am).
- Independently determine approach to managing daily operations (guided by policies/management guidance).
- Develop/provide procedures and standards; interpret and execute standards affecting work activities.
- Develop and communicate goals/objectives to staff and key partners; monitor performance and coordinate improvements via OPEX.
- Represent Quality Assurance on incident triage teams; provide guidance/technical leadership.
- Partner with management levels to resolve issues, establish direction, obtain resources, and drive change.
- Review/approve operational and manufacturing procedures; approve process validation protocols/reports, environmental characterization reports, and change control documents.
- Approve non-conformances; represent QA on project teams; approve change-over completion controls.
- Lead investigations, plant, and site audits.
Basic Qualifications (choose one)
- High school diploma/GED + 12 years Quality or Manufacturing experience OR
- Associate’s + 10 years OR
- Bachelor’s + 5 years OR
- Master’s + 3 years OR
- Doctorate.
- Plus experience managing people and/or leadership experience leading teams/projects/programs or directing resource allocation.
Preferred Qualifications
- Bachelor’s in Life Sciences/Engineering or related; 6+ years biotech/pharma QA (or combined QA/manufacturing); 2+ years supervisory/management.
- Experience with manufacturing, investigations, CAPA, product release, validation, and/or change control; biotech multi-product regulations/standards.
- Knowledge of monoclonal antibody manufacturing; risk-based decision-making; clear communication and collaboration.
Total Rewards Plan (benefits listed)
- Health/welfare, retirement savings contributions, life/disability, flexible spending, discretionary bonus (or sales incentive), stock-based long-term incentives, time-off plans; flexible work models where possible.
Application Instructions
- Apply via careers.amgen.com; no application deadline (accepted until sufficient candidates or selection).