Job Summary
A biopharmaceutical services organization is filling a position for a Remote Technical Compliance Vice President.
Must be able to:
- Conduct data integrity assessments, evaluation and remediation activities
- Perform mock Pre-Approval inspections and remediation of identified gaps
- Assist clients with FDA-483 & Warning Letter responses
Must meet the following requirements for consideration:
- Domestic and International Travel Required
- 25 years of relevant experience, with at least 15 years of FDA experience
- Advanced degree in a relevant technical/scientific or business domain
- Must have high name recognition within the GMP/regulatory domain
- Experience in the FDA that is in line with the job description
- Senior current FDA official, or ex-FDA official with successful post-FDA leadership roles in GMP