QA Manager

OPM Biosciences; Pleasanton (CA); Sur place; USD 120 000 - 180 000; Plein temps

Avantages offerts par ce poste

Start-up pace

Competitive compensation

Résumé du poste

OPM Biosciences in Pleasanton, CA seeks a QA leader to oversee phase-appropriate QMS, document control, deviations, CAPA and training. You will drive data-integrity, biosafety compliance, and audits across biologics development and cell culture operations.

The role requires 6+ years in quality within biologics or adjacent life-sciences manufacturing, with hands-on CLD/cell culture workflows and pilot-scale media production experience.

Qualifications

• Lead QA activities for biologics and cell culture development.
• Oversee deviations, CAPA, investigations and change control.
• Manage document control and batch review.
• Coordinate with EHS on biosafety and waste management.
• Lead internal and client audits.
• Coach R&D/Operations on quality best practices.
• Build and maintain QA team.
• Ensure compliance with cGMP and ISO standards.

Responsabilités

• Stand up and maintain a phase-appropriate QMS aligned with cGMP and ISO 9001/13485.
• Own document control, training, deviations/investigations, CAPA and management review.
• Implement data-integrity by design (ALCOA+).
• QA oversight of cell banking, biosafety, and material control.
• Review study plans, protocols/reports and reference standards control.
• Approve changes, investigations, and corrective actions.

Connaissances

QA leadership

cGMP knowledge

ISO 9001/13485

Data integrity ALCOA+

Cross-functional comms

Cell culture workflows

Pilot-scale production

Formation

Bachelor’s in life sciences or engineering

Outils

eQMS/LIMS

Description du poste

• 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.
• 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.

What you’ll bring

• 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.

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.