Senior OTC Compliance Auditor – Great opportunity for former FDA Inspectors

Job not on LinkedIn

🔥 13 hours ago

🇵🇱 Poland – Remote

⏰ Full Time

🟠 Senior

🔎 Auditor

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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SGS

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1878

💼 Consulting

🏥 Healthcare

🍽️ Food & Beverage

Consulting • Healthcare • Food & Beverage

SGS is the world's leading Testing, Inspection, and Certification (TIC) company, providing a comprehensive range of services designed to assure quality and integrity across various sectors. SGS is focused on sustainability, offering climate action services and an all-encompassing ESG portfolio under its IMPACT NOW suite. The company has ambitious targets for growth by 2027, driven by its strategy to address global megatrends. SGS operates globally, providing business assurance, connectivity and products, digital trust, health and nutrition, and solutions for industries and the environment.

📋 Description

• 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 audit reports with observations and recommended corrective actions • Support 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 • Independently manage scheduling, travel, and deliverables as an external contractor

🎯 Requirements

• 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 • Willingness and ability to travel internationally, outside of North America, for the duration of the contract • Must be authorized to work in Canada for Canadian job openings

🏖️ Benefits

• Full-time employment • International client engagements • Equal Opportunity Employer • Reasonable accommodations available during each stage of the recruitment process