Phil Lynch

Phil Lynch

Senior Biotech Consultant, Pharma and Biotech

Health Sciences

North America

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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 organisations 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 commercialisation.

Phil is an expert in full quality system development, implementation and remediation and specialises 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 sterilisation)
  • Clinical stage QA support
  • Greenfield site and QMS development
  • CDMO/CMO/vendor qualification and management

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