QA Manager

OPM BIOSCIENCES INC; Pleasanton (CA); On-site; USD 170,000 - 230,000; Full time

Job summary

Intuit, Inc. is seeking a senior QA leader to drive quality management across biologics, cell culture, and media production.

You will own CLD workflows, supplier quality, audits, and validation strategies to ensure GMP readiness and continuous improvement. You will partner with R&D and operations to embed quality by design, ALCOA+ data integrity, and phase-appropriate compliance from development to scale-up.

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 CLD/cell culture workflows and pilot-scale media production experience.
• Strong command of cGMP principles, ISO 9001/13485, ICH Q7/Q9, data integrity (ALCOA+), and phase-appropriate compliance for R&D to clinical scale-up.
• Proven track record standing up QMS elements (deviations/CAPA, change control, doc control, batch review, training).
• Exposure to equipment/utilities qualification (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; advanced degree a plus.

Responsibilities

• Lead QMS elements and ensure readiness for GMP, including deviations, CAPA, change control, and document control.
• Oversee CLD/cell culture workflow QA oversight, including cell banking qualification, traceability, and reference standards control.
• Manage small-scale media production QA oversight, batch records, in-process specs, and environmental monitoring.
• Qualify raw-material suppliers, set inbound inspection plans, and maintain ASL.
• Lead internal audits and support client audits; develop validation/qualification strategies for GMP readiness.
• Coach R&D/Operations on quality best practices and drive continuous improvement.

Skills

Quality leadership

Cell culture QA

GMP compliance

Data integrity (ALCOA+)

QMS implementation

Cross-functional communication

Education

Bachelor’s in life sciences or engineering

Advanced degree preferred

Tools

eQMS/LIMS

EM programs

Job description

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/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 to 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.

Nice to have

• 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.