Manager Quality Assurance - PQA
Amgen · Holly Springs, NC
QualityFull-timeCompany career page
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Role summary
Manager Quality Assurance role supporting the startup and operations of a new biomanufacturing facility in North Carolina. Responsibilities include leading a QA team, overseeing GMP compliance, managing regulatory readiness, and supporting facility startup activities across manufacturing and engineering functions.
What they're looking for
- Doctorate degree, or Master's with 3+ years quality experience, or Bachelor's with 5+ years quality experience
- Direct people management experience and/or team leadership experience
- Experience in quality, manufacturing, operational excellence, engineering, or related technical fields
- Knowledge of CDOCS, Trackwise, Maximo, LIMS, MES Werum, or similar systems preferred
- Strong written and verbal communication skills with technical writing capability
- Ability to manage multiple competing priorities in fast-paced environment
What you'll be doing
- Oversee startup activities for facilities, utilities, equipment, systems, and processes at the new North Carolina facility
- Hire, train, develop, and manage Quality Assurance professionals supporting GMP manufacturing operations
- Manage team performance, development, and daily operations including training and task prioritization
- Provide quality oversight and develop procedures ensuring products meet manufacturing, testing, and storage standards
- Partner with manufacturing, facilities, engineering, and other functions on deviations, quality systems, and compliance matters
Privacy & handoff
This role links to Amgen's own application system. RoleLantern records your interest and checks the link, but the application happens on the employer's site and status updates may not come back to us. Clicking apply does not mark you as applied automatically.