Senior GMP/GLP Quality Systems Audit Lead (Onsite – Northern CA)

The FDA Group; San Francisco (CA); On-site; USD 150,000 - 210,000; Full time

Job summary

The FDA Group is seeking an experienced GMP/GLP & Quality Systems Audit Consultant to conduct a thorough three-day onsite audit of a life sciences testing facility in Northern California. You will assess laboratory operations, quality systems, room classifications, equipment maintenance, and Quality Unit oversight to identify gaps and risks.

The engagement emphasizes practical, risk-based recommendations and a comprehensive audit report, with follow-up audits anticipated to evaluate progress and

Qualifications

• Significant experience conducting audits in pharmaceutical, biotechnology, life sciences testing, or similarly regulated environments.
• Auditing expertise relevant to laboratory operations and quality systems.
• Knowledge across microbiology, environmental monitoring, virology, molecular services and/or chemistry.
• Experience evaluating facility and laboratory controls, including room classifications, equipment maintenance and Quality Unit functions.
• Ability to translate audit findings into clear, actionable observations and recommendations.
• Strong audit report writing and communication skills.
• Willingness to conduct a three-day onsite audit in Northern California.

Responsibilities

• Plan and execute a comprehensive three-day onsite facility audit.
• Assess microbiology and environmental monitoring operations and controls.
• Review virology, molecular and chemistry laboratory activities within the audit scope.
• Evaluate room classifications and applicable environmental controls.
• Assess equipment suitability and maintenance programs.
• Evaluate Quality Unit functions and oversight of lab and facility activities.
• Assess GMP/GLP practices and supporting Quality Systems.
• Identify compliance gaps, risks and opportunities for improvement.
• Document audit observations and provide practical recommendations.
• Prepare a clear, comprehensive audit report after onsite assessment.
• Collaborate with subject matter experts if needed for full scope.
• Support efficient audit and reporting aligned with the engagement timeline.

Job description

The FDA Group is seeking an experienced GMP/GLP & Quality Systems Audit Consultant to conduct a thorough three-day onsite audit of a life sciences testing facility in Northern California. You will assess laboratory operations, quality systems, room classifications, equipment maintenance, and Quality Unit oversight to identify gaps and risks.

The engagement emphasizes practical, risk-based recommendations and a comprehensive audit report, with follow-up audits anticipated to evaluate progress and