Quality Assurance Manager

OPM Biosciences; Pleasanton (CA); On-site; USD 180,000 - 260,000; Full time

Job summary

OPM Biosciences in the United States seeks a founding QA leader to build and run the Quality Management System across U.S. operations.

You will own document control, deviations/CAPA, batch record review, supplier quality, and lot release, ensuring GMP readiness as we scale and expand cell culture and media production. You will lead a hands-on team, implement ALCOA+ data integrity, and partner with R&D and operations to embed quality by design.

Qualifications

• 6+ years in Quality within biologics or cell culture manufacturing.
• 2+ years in a QA lead/manager role.
• Hands-on CLD cell culture workflows and pilot-scale media production.
• Strong knowledge of cGMP, ISO 9001/13485, ICH Q7/Q9, data integrity (ALCOA+).
• Experience establishing QMS elements (deviations/CAPA, change control, doc control, batch review, training).
• Familiarity with equipment qualification, EM programs, and cleaning validation.

Responsibilities

• Build and lead the QA function for U.S. operations.
• Develop and implement a scalable QMS aligned with GMP, ISO, and quality risk management.
• Oversee document control, deviations, CAPA, batch release, supplier quality, and audits.
• Ensure biosafety and compliance in BSL-2 labs; manage quality systems for CLD and media.
• Lead internal and client audits and manage responses.
• Coach R&D/Operations on quality best practices and continuous improvement.

Skills

Quality leadership

cGMP knowledge

Data integrity

Cross-functional communication

Training & coaching

Lean Six Sigma

Education

Bachelor's in life sciences or engineering

Advanced degree a plus

Tools

eQMS

LIMS

Job description

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 hand-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.
• 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/6 sigma 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 hand-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.