Manager Quality Assurance - PQA

Role: Manager Quality Assurance for the Pharmaceutical Quality Assurance (PQA) team supporting the startup and operational transition of Amgen's new biomanufacturing facility in Holly Springs. Objectives include overseeing GMP manufacturing compliance, building and leading a team, and ensuring facility readiness for production. Responsibilities encompass managing qualification activities, reviewing and approving quality documentation, supervising team performance, supporting inspections, and partnering with manufacturing and engineering for quality integration. Qualifications require a Bachelor's degree with 5+ years of quality experience, managerial experience, and familiarity with GMP and validation processes. Preferred skills include experience with systems like Trackwise, LIMS, MES, and knowledge in manufacturing investigations, CAPA, change control, and validation. High-value specifics include biomanufacturing of biologics, construction and startup of a multi-product facility, integration of digital and sustainable manufacturing innovations, and support for regulatory compliance and inspection readiness. The role involves on-site work with shift support, including late afternoons and nights, and requires experience managing fast-paced project priorities in a biotech manufacturing environment.