[Hiring] Senior OTC Compliance Auditor @SGS

Role 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.

• 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.

Requirements

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

Company Description

We are SGS – the world's leading testing, inspection and certification company. We are recognized as the global benchmark for sustainability, quality and integrity. Our 99,600 employees operate a network of 2,600 offices and laboratories, working together to enable a better, safer and more interconnected world.