Senior OTC Compliance Auditor (FDA)

Location: Remote, United States; international travel outside North America is required for the contract duration.

Company

hirify.global is a global testing, inspection, and certification company focused on sustainability, quality, and integrity.

What you will do

• 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.
• Manage scheduling, travel, and deliverables independently during international client engagements.

Requirements

• Former FDA Investigator or Inspector required.
• 3–5 years of auditing experience in OTC or pharmaceutical manufacturing.
• Strong knowledge of cGMP requirements, OTC monograph expectations, and FDA enforcement practices.
• Ability to conduct independent, high-level audits and clearly communicate findings.
• Excellent communication and technical writing skills.
• Must be willing and able to travel internationally outside North America for the duration of the contract.

Culture & Benefits

• Short-term contract assignment running from May through August 2026.
• Independent external-contractor arrangement with responsibility for scheduling and deliverables.
• Work supporting clients in the international OTC pharmaceutical industry.
• Equal opportunity employer with accommodations available during the hiring process.