Phillip Lynch
Senior Quality Assurance Consultant
Mr. Lynch is a results-driven quality professional with over 30 years of leadership in the pharma, biotech, medical device, and consumer industries. Products include liquids, solids, suspensions, aseptic LVP/SVP processing/filling, lyophilized products, biologics, vaccines and automated/serialized packaging. He also has strong background in Regulatory body and QMS management.
Phil has a track record of enabling business through the principles of quality as a competitive advantage, ensuring that products are available on time with superior quality. He is a decisive, innovative and pragmatic leader who works collaboratively and cross functionally across organizations to deliver strategic value for Quality, Operations, Supply Chain, and R&D.
Mr. Lynch served has an executive with leadership experience in both large and small organizations. He brings his strong knowledge and application of (c)GMP’s, Health Canada Policies/Regs, FDA/EU GMP, ICH guidelines, and ISO 9001/13485/CMDCAS. He holds a degree in Chemistry with a minor in Economics from McMaster University.
Core Competencies
- ASQ Certified Auditor
- Biologics/Sterile Products
- GxP Quality Systems
- GMP Audit Procedures
- Biologics API
- CMO/CRO Management
- Clinical QA Design
- Vendor Qualifications
- Quality Agreements
- QA/QC Validation
- Project Management
