GMPGLP Quality Systems Audit Consultant

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

GMP/GLP & Quality Systems Audit Consultant

Location: Northern California
Work Arrangement: Onsite for audit execution
Duration: Three-day facility audit, with report preparation following the audit
Start: Before the end of October
Travel: Onsite presence required

Position Overview

We are seeking an experienced GMP/GLP and Quality Systems Audit Consultant to conduct a comprehensive three-day onsite audit of a life sciences testing facility in Northern California.

The audit will assess laboratory operations and supporting quality systems across microbiology, environmental monitoring, virology, molecular services, and chemistry. The scope will also include room classifications, equipment suitability, maintenance programs, and Quality Unit functions.

The consultant will identify compliance gaps, areas of risk, and improvement opportunities and provide a clear, technically credible audit report with practical, risk-based recommendations. A follow-up audit is anticipated in the following year to evaluate progress and implemented improvements.

Key Responsibilities

• Plan and execute a comprehensive three-day onsite facility audit.
• Assess microbiology and environmental monitoring operations and associated controls.
• Review virology, molecular, and chemistry laboratory activities within the defined audit scope.
• Evaluate room classifications and applicable environmental controls.
• Assess equipment suitability, qualification status as applicable to the audit scope, and maintenance programs.
• Evaluate Quality Unit functions and oversight of laboratory and facility activities.
• Assess applicable GMP/GLP practices and supporting Quality Systems.
• Identify compliance gaps, areas of risk, and opportunities for improvement.
• Document audit observations and provide practical, risk-based recommendations.
• Prepare a clear and comprehensive audit report following completion of the onsite assessment.
• Collaborate with additional audit subject matter experts if multiple auditors are needed to adequately cover the technical scope.
• Support an efficient audit and reporting process aligned with the engagement timeline.

Required Qualifications

• Significant experience conducting audits within pharmaceutical, biotechnology, life sciences testing, or similarly regulated environments.
• Demonstrated auditing expertise relevant to laboratory operations and quality systems.
• Technical knowledge applicable to multiple areas within the audit scope, including microbiology, environmental monitoring, virology, molecular services, and/or chemistry.
• Experience evaluating facility and laboratory controls, including room classifications, equipment suitability, maintenance programs, and Quality Unit functions.
• Ability to identify meaningful compliance risks and translate audit findings into clear, actionable observations and recommendations.
• Strong audit report writing and communication skills.
• Ability and willingness to conduct the three-day audit onsite in Northern California.

Preferred Qualifications

• Former FDA inspection or auditing experience is preferred but not required.
• Broad experience auditing complex laboratory environments encompassing multiple scientific disciplines is preferred.

Work Arrangement

The engagement requires onsite presence for the three-day facility audit. Audit report preparation will follow the onsite assessment, with standard delivery expected within approximately 30 days after the audit. An expedited report turnaround may be requested based on project timing.

Ideal Candidate

The ideal consultant is a seasoned auditor with strong laboratory and Quality Systems expertise who can independently assess a multidisciplinary testing environment, identify meaningful compliance and operational gaps, and produce a clear, actionable audit report. Former FDA experience is valuable, but directly relevant technical expertise and a strong audit track record are the primary considerations.