QA Leader: Build GMP-Ready QMS for Biologics

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

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.