Quality Assurance Manager

Job Description

Job Description

Job Title: Quality Assurance Manager
Location: Pleasanton, CA (Onsite)
Position Type: Full Time

Job Description:

As the QA Manager, you’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.

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.

Qualifications:

• Bachelor's degree in life sciences, engineering, or a related field; an advanced degree is a plus.
• 6+ years of Quality experience in biologics/biopharma GMP environments and 2+ years in a QA lead or manager role.
• Direct experience in one or more of the following: CLD, cell culture, RCB/WCB cell banking, or cell culture media.
• Demonstrated experience building QMS elements from scratch, not solely maintaining an established quality system.
• Hands-on experience with batch record review, lot release, deviations/CAPA, change control, document control, training, and supplier quality.
• Strong understanding of cGMP, applicable ISO 9001/13485 practices, ICH Q9, ALCOA+, and phase-appropriate compliance for R&D-to-clinical scale-up.
• Ability to work hands-on in a startup environment and collaborate effectively with scientists and manufacturing teams.

Preferred Experience:

• Experience in biologics CDMOs, biopharma startups, cell culture media production, or related biologics manufacturing and development environments.
• Familiarity with powder and/or liquid media production, equipment and utilities qualification, cleanrooms, environmental monitoring, sterile filtration, endotoxin control, and cleaning validation.
• Experience with eQMS/LIMS, client audits, calibration and metrology programs, EMS/BMS, and contractor oversight.
• Working knowledge of EHS, biosafety, hazardous materials handling, and waste management requirements in California.