Quality Assurance Manager
About the roleYou’ll build and run the Quality System for our U.S. R&D and pilot operations—covering cell line development (CLD), cell culture process development, and small-scale powder/liquid media production. You’ll own document control, deviations/CAPA, batch record review, supplier quality, and lot release, while getting the site “GMP-ready” as we scale.What you’ll doQuality 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.What you’ll bring· 6+ years in Quality within biologics, cell culture, media, CDMO, or adjacent life-sciences manufacturing; 2+ years in a QA lead/manager role.· Hands-on experience with CLD/cell culture workflows and pilot-scale media production (powder and/or liquid).· Strong command of cGMP principles, ISO 9001/13485, ICH Q7/Q9, data integrity (ALCOA+), and phase-appropriate compliance for R&D → clinical scale-up.· Proven track record standing up QMS elements (deviations/CAPA, change control, doc control, batch review, training).· Exposure to equipment/utilities qualification (e.g., cleanrooms, HVAC, PW/DI water, cold rooms), EM programs, and quality risk management.· Excellent cross-functional communication; comfortable working with both scientists and operators.· Bachelor’s in life sciences or engineering required; advanced degree a plus.Nice to have· Start-up/CDMO experience; client-audit hosting.· eQMS/LIMS experience; statistics for trending (e.g., control charts, process capability).· Familiarity with sterile filtration, endotoxin control, and cleaning validation for media operations.Compensation & benefits· Competitive base salary + bonus.· Health, dental, vision; 401(k); paid time off.Equal OpportunityWe celebrate diversity and are committed to creating an inclusive environment for all employees.