Title: Senior FDA Quality / Compliance Consultant
Job Type: Contract and Employee Relationships Available
Opportunity Information:
Senior manufacturing, quality and regulatory professional with 20+ years of experience across regulated product classes including pharmaceuticals and medical device. Strong project leadership abilities necessary to work with clients to develop quality assurance and regulatory strategies for compliance with FDA regulations. Demonstrated accomplishments in:
- Quality System development, enhancement, and harmonization
- Quality System assessments, audits and associated reports
- Due diligence pertaining to acquisition and licensing agreements
- Compliance investigations and reviews
- Advising ‘in crisis’ companies dealing with critical enforcement action
- Non-conformance investigations, deviation and CAPA investigations and reports
- Software validation, design control, process validation
- Analytical lab, quality control, supplier quality, calibration, corrective action
Preferred Education:
Degree in engineering, pharmacy, bioengineering, medical technology, biology, chemistry or related technical discipline required.
