Phil Lynch

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