QA Manager

Job Description Job Description Key Responsibilities Quality Management System (QMS) Stand up and maintain a phase-appropriate QMS (SOPs, forms, records) aligned with cGMP principles, ISO 9001/13485 good practices, and ICH Q9 risk management. Own document control, training, change control, deviations/investigations, CAPA, and management review. Implement data-integrity by design (ALCOA+), including audit trails and controlled lab notebooks/eQMS.CLD & Cell Culture Development QA Oversight QA oversight of cell banking (RCB/WCB): qualification, traceability, storage, chain-of-custody. Ensure biosafety & compliance for BSL-2 labs; oversee mycoplasma/sterility policies & materials control. Review study plans, protocols/reports (DoE, comparability), and ensure reference standards control. Approve deviations, investigations, and corrective actions tied to development studies. Small-Scale Media Production QA Oversight Establish batch record issuance, review, and lot release (spec, COA, label control).Define in-process/finished product specs (appearance, pH, osmolality, bioburden/endotoxin, clarity, assay).Oversee equipment qualification (IQ/OQ/PQ), calibration, maintenance logs, and cleaning validation. Set up environmental monitoring (ISO-classified rooms as applicable) and gowning/behavioral controls. QA support for sterile filtration (filter integrity), powder blending, mixing, packaging, and labeling. Supplier & Materials Quality Qualify raw-material suppliers (audits/questionnaires), set incoming inspection plans, manage SCARs. Define material specifications and change-notification requirements; maintain approved supplier list (ASL).Audits, Compliance & Readiness Lead internal audits; host client audits; coordinate responses/closure. Build phase-appropriate validation/qualification and change-management strategies for GMP readiness. Partner with EHS on biosafety/chemical compliance and waste management. People, Training & Culture Build a small but high-performing QA team; coach R&D/Operations on quality best practices. Own quality training curricula and effectiveness checks across functions. Champion continuous improvement (Lean/6σ mindset) and right-first-time execution.