Manager, Quality Assurance

Position Summary

As the founding QA leader for our U.S. operations, you will build, implement, and lead the Quality Management System—covering cell line development (CLD), cell culture process development, and small-scale powder/liquid media production. This is a hands-on leadership role responsible for establishing scalable quality systems, overseeing core QA functions including document control, deviations/CAPA, batch record review, supplier quality, and lot release, while getting the site “GMP-ready” as we scale.

Key Responsibilities

Quality Management System (QMS)

• Build 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

• Lead 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.

• Drive 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

• Lead Qualification of 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 and lead a 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.

Qualifications

• 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.

Preferred Qualifications

• 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.

Ideal Candidate

Someone who has built quality systems from the ground up and thrives in startup environments where you define the standards rather than maintain them. A hands-on leader who balances strategic thinking with execution speed, driving GMP readiness without over-engineering processes, and building a quality culture that enables the business rather than slowing it down. 

Equal Opportunity Employer

We are an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other characteristic protected by applicable law.