Manager Quality Assurance - PQA
Core
Manager Quality Assurance leading the startup and transition to ongoing bulk drug substance manufacturing for the Amgen North Carolina (ANC) facility, ensuring compliance with cGMP and managing the PQA team.
Role type
Manager Quality Assurance (Plant Startup & Operations)
Builds
Bulk drug substance manufacturing operations and facility startup readiness
Domain
Biotechnology / Pharmaceutical Manufacturing
Required skills
Quality Assurance management, cGMP compliance, team leadership, change management, validation oversight, deviation management, regulatory inspection readiness, SOP development, risk assessment
Preferred skills
Life Sciences or Engineering degree, experience with CDOCS/Trackwise/Maximo/LIMS/MES, CAPA management, multi-product environment experience, technical writing, complex problem solving
Technologies
CDOCS, Trackwise, Maximo, LIMS, MES Werum
Responsibilities
Oversee ANC startup activities for facilities, utilities, equipment, systems and processes; Hire, train, develop, and manage Quality Assurance professionals; Oversee execution of factory acceptance, commissioning tests, facility qualifications and validation activities; Provide on-going Quality oversight to ensure products are manufactured according to cGMP; Participate in Inspection Readiness program activities; Review and approve operational and product manufacturing procedures and validation protocols
Seniority
Manager, hands-on leadership