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

Job description

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

Qualifications

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.