Contract Opportunity - Senior OTC Compliance Auditor (Great opportunity for former FDA Inspectors)

We are seeking a highly experienced Subcontractor – Senior OTC Compliance Auditor with a background as a former FDA Investigator/Inspector. This short-term assignment (May-August 2026) requires expertise in OTC drug manufacturing, cGMP compliance, and FDA inspection methodology.

As a subcontractor, you will support audits, inspection readiness activities, and compliance reviews for clients in the OTC pharmaceutical industry. 

Key Responsibilities

• Conduct cGMP compliance audits of OTC drug manufacturing, packaging, labeling, and laboratory operations.
• Apply FDA inspection methodology to identify compliance gaps, risks, and deficiencies.
• Prepare detailed, professional audit reports outlining observations and recommended corrective actions.
• Support clients with mock FDA inspections, inspection readiness activities, and compliance remediation.
• Review quality systems, SOPs, batch records, data integrity controls, and laboratory practices.
• Represent the organization professionally during international client engagements.
• Manage scheduling, travel, and deliverables independently as an external contractor

• Former FDA Investigator/Inspector (required).
• 3–5 years of auditing experience within OTC or pharmaceutical manufacturing.
• Strong understanding of cGMP requirements, OTC monograph expectations, and FDA enforcement practices.
• Proven ability to conduct independent, high‑level audits and articulate findings clearly.
• Excellent communication and technical writing skills.

Travel

• Must be willing and able to travel internationally, outside of North America, for the duration of the contract.

Interested?

If you’re a former FDA inspector with OTC auditing experience and open to a global contract assignment, we’d like to connect.