Senior QA Manager - Biologics & Cell Culture Operations

OPM Biosciences; Pleasanton (CA); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Start-up pace

Competitive compensation

Job summary

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.

Responsibilities

• 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.

Skills

QA leadership

cGMP knowledge

ISO 9001/13485

Data integrity ALCOA+

Cross-functional comms

Cell culture workflows

Pilot-scale production

Education

Bachelor’s in life sciences or engineering

Tools

eQMS/LIMS

Job description

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.