Seasoned Quality Leader
Quality Assurance executive with 25 years of big Pharma experience, more than 10 years with emerging pharma and biotech companies managing their CMOs, and as VP of quality at a CMO, providing me with the experience of managing that type of relationship from both sides of the table. Now independent and providing cost effective contract QA solutions to companies advancing compounds through the clinical development cycle.
Relevant Therapeutic Areas
- Rare diseases
- Allergy / Immunology
- Cardiovascular Diseases
- Pulmonology / Respiratory Diseases
- Ophthalmology
- Infectious diseases
Product Technologies
- Biologics
- DNA & RNA Therapeutics
- Drug Delivery
- Monoclonal Antibody
- Recombinant Products
- Small Molecules
Recent Titles
- Vice President, Quality Assurance
- Director, Corporate Quality Assurance
- Director, Quality Assurance
Location
- Mid-Atlantic Region
- Open to remote, travel, and in-office
Relevant Companies
- Insmed
- Schering-Plough
- OPKO
- Small & Medium-Sized Biotechs
Skills & Accomplishments
- Quality Management of CMOs and CTOs
- Investigations of deviations, Root Cause Analysis and CAPA management
- Design and implement Quality system infrastructure appropriate for the stage of development
Training - Preparation of CMC documentation in support of filings
- Preparation for Pre-approval inspections