Phil Lynch has over 30 years of quality and regulatory affairs management experience in the pharmaceutical, medical device, ISO 9001 and cannabis (regulated) industries in multi-site plant operations oversight and corporate offices.
Phil has supported many pre-commercial/clinical stage organizations most recently as Head of Quality and Regulatory Affairs at Precision NanoSystems, a pre-clinical, Ph1/2 SaRNA CDMO and liquid nano-particle equipment manufacturer. He has consulted for several large and small molecule companies from pre-clinical through to commercialization.
Phil is an expert in full quality system development, implementation and remediation and specializes in investigation management, batch disposition, change control, validation/qualification, and vendor management. He can support phase appropriate scale at any stage of development.
His areas of expertise include:
- QMS development, implementation, and remediation support
- Investigations and deviation management
- Sterile manufacturing (aseptic and terminal sterilization)
- Clinical stage QA support
- Greenfield site and QMS development
- CDMO/CMO/vendor qualification and management