GMP-Ready QA Leader for Biotech/Cell Culture

OPM Biosciences; Pleasanton (CA); On-site; USD 180,000 - 240,000; Full time

Job summary

OPM Biosciences in Pleasanton, CA seeks a founding QA leader to build, implement, and scale the Quality Management System across cell line development, cell culture, and small-scale production. This hands-on leadership role oversees document control, deviations/CAPA, batch review, supplier quality, and lot release to drive GMP readiness.

You will recruit and lead a high-performing QA team, define training curricula, and partner with R&D and Operations to embed quality by design, ALCOA+ data

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.
• Strong command of cGMP, ISO 9001/13485, ICH Q7/Q9, data integrity (ALCOA+).
• Proven track record standing up QMS elements (deviations/CAPA, change control, doc control, batch review, training).
• Exposure to equipment qualification (cleanrooms, HVAC, PW/DI water, cold rooms), EM programs, and quality risk management.
• Excellent cross-functional communication; comfortable with scientists and operators.
• Bachelor's in life sciences or engineering; advanced degree a plus.

Responsibilities

• Build and lead a phase-appropriate QMS aligned with cGMP principles and ICH 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.
• Lead QA oversight of CLD/cell culture workflows, qualification, traceability, and storage.
• 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 specs (COA, label control).
• Define material specs and change-notification requirements; maintain ASL with suppliers.
• Lead internal audits; host client audits; coordinate responses/closure.
• Build QA team; coach R&D/Operations on quality best practices; training curricula.

Skills

QA leadership

cGMP awareness

Data integrity

Cross-functional communication

Startup/scale-up

Education

Bachelor's in life sciences or engineering

Advanced degree beneficial

Tools

eQMS

LIMS

Audit management systems

Job description

OPM Biosciences in Pleasanton, CA seeks a founding QA leader to build, implement, and scale the Quality Management System across cell line development, cell culture, and small-scale production. This hands-on leadership role oversees document control, deviations/CAPA, batch review, supplier quality, and lot release to drive GMP readiness.

You will recruit and lead a high-performing QA team, define training curricula, and partner with R&D and Operations to embed quality by design, ALCOA+ data