Quality Assurance Manager

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

Job Description:

As the QA Manager youll build and run the Quality System for our U.S. R&D and pilot operationscovering cell line development (CLD) cell culture process development and small-scale powder/liquid media production. Youll 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.

• 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.

• 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.

• Qualify raw-material suppliers (audits/questionnaires) set incoming inspection plans manage SCARs.
• Define material specifications and change-notification requirements; maintain approved supplier list (ASL).

• 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.

• 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.

• Bachelors 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.

• 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.