Subcontractor Senior OTC Compliance Auditor (Great opportunity for former FDA Inspectors)
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Job Location:
Monthly Salary:
Posted on:
3 hours ago
Vacancies:
1 Vacancy
Job Summary
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).
- 35 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 highlevel 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 youre a former FDA inspector with OTC auditing experience and open to a global contract assignment from MayAugust 2026 wed 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 companys 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
Remote Work :
Yes
Employment Type :
Full-time
Key Skills
- Compliance Management
- Risk Management
- Financial Services
- PCI
- Banking
- Cost Accounting Standards
- Quality Systems
- Research Experience
- NIST Standards
- Securities Law
- SOX
- ISO 27000
About Company
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 ... View more
