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Senior QA/RA Advisor – FDA Compliance & GAP Remediation (M/F/D)
Tasks:
- Provide strategic regulatory guidance for FDA submission of an ophthalmic product (New Drug Application)
- Validate and enhance an existing GAP analysis (MDR vs. 21 CFR Part 211)
- Support the further development and execution of an existing remediation plan
- Advise on investment decisions related to FDA compliance and site readiness
- Drive project success and collaborate closely with the inhouse teams
- Conduct regular status check-ins (monthly) and ensure alignment with the project plan
Qualification:
- In-depth knowledge of FDA regulations, particularly 21 CFR Part 211
- Proven experience in U.S. market submissions for pharmaceutical products (e.g., sterile ophthalmic solutions, injectables)
- Ideally, previous experience within a CDMO environment
- Hands-on experience with GAP analysis and remediation processes
- Strong communication and project management skills in an international project setting
Requirements:
Start: asap
Duration: 6-12 months
Capacity: 3-5 days per week
Location: remote
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