Quality Assurance Manager

Familiarity with powder and/or liquid media production, equipment and utilities qualification, cleanrooms, environmental monitoring, sterile filtration, endotoxin control, and cleaning validation. 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.

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.