Senior OTC Compliance Auditor – Great opportunity for former FDA Inspectors

This is a fully remote position, open to applicants in Poland.

📋 Description

• Execute cGMP compliance audits for OTC drug manufacturing, packaging, labeling, and laboratory operations.

• Utilize FDA inspection methodologies to pinpoint compliance gaps, risks, and deficiencies.

• Draft comprehensive audit reports detailing observations and suggesting corrective actions.

• Assist with mock FDA inspections, inspection readiness activities, and compliance improvement efforts.

• Evaluate quality systems, SOPs, batch records, data integrity controls, and laboratory practices.

• Professionally represent the organization during international client interactions.

• Independently oversee scheduling, travel arrangements, and deliverables as an external contractor.

⛳️ Requirements

• Previous experience as an FDA Investigator/Inspector (mandatory).

• 3–5 years of auditing experience in OTC or pharmaceutical manufacturing.

• Strong comprehension of cGMP requirements, OTC monograph expectations, and FDA enforcement practices.

• Demonstrated ability to carry out independent, high-level audits and communicate findings effectively.

• Exceptional communication and technical writing abilities.

• Willingness and capability to travel internationally, beyond North America, for the duration of the contract.

• Must have authorization to work in Canada for job openings based in Canada.

🏝️ Benefits

• Full-time employment.

• Opportunities for international client engagements.

• Equal Opportunity Employer.

• Reasonable accommodations provided throughout all stages of the recruitment process.