QA Manager

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.

• 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.