Manager Quality Assurance - PQA
Core
Lead Quality Assurance for the startup and transition of a new biomanufacturing facility in North Carolina, ensuring compliance with GMP during development, clinical, launch, and commercial operations.
Role type
Manager, Quality Assurance (Manufacturing)
Builds
New multi-product drug substance biomanufacturing facility (FleX Batch technology)
Domain
Biotechnology / Pharmaceutical Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work -> physical/clinical work (Manufacturing facility startup and operations)
Required skills
GMP compliance, team management, change control, deviation management, inspection readiness, process validation, risk-based decision-making
Preferred skills
CDOCS, Trackwise, Maximo, LIMS, MES Werum, CAPA, manufacturing investigations, scientific data analysis
Technologies
CDOCS, Trackwise, Maximo, LIMS, MES Werum
Responsibilities
Oversee ANC startup activities for facilities, utilities, equipment, systems and processes; Manage a team of PQA staff and their daily operations; Participate in Inspection Readiness program activities; Review and approve operational and product manufacturing procedures, process validation; Support site audits and inspections.
Seniority
Manager, hands-on leadership