Senior OTC Compliance Auditor

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.

Additional Information

SGS is an Equal Opportunity Employer, and as such we recruit, hire, train, and promote persons in all job classifications without regard to race, color, religion, sex, national origin, disability, age, marital status, sexual orientation, gender identity or expression and Indigenous status, or any other characteristics protected by law.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily with or without reasonable accommodations. The requirements listed above are representative of the knowledge, skills, and/or abilities required.

This job description should not be construed as an exhaustive statement of duties, responsibilities, or requirements, but a general description of the job. Nothing contained herein restricts the company's rights to assign or reassign duties and responsibilities to this job at any time.

Accommodations are available on request for qualified candidates during each stage of the recruitment process.

Please note that candidates applying for Canadian job openings should be authorized to work in Canada