Gerry McKiernan

Partner / Director


Over 20 years’ experience in the ATMP, Biologics, Medical Device and Pharmaceutical industries with extensive systems knowledge across Quality and Operations Management. Experienced in working within multinational pharma, CDMO’s and startup companies. 

Career achievements include securing Australia’s first commercial cell therapy licence for CAR-T products with additional licences secured for supply to Japan, Republic of Korea, Taiwan and Hong Kong. Gerry has successfully led QMS and Facility Operations establishment plans for new aseptic cell therapy facilities in Japan and China and has managed Quality and Regulatory aspects for over 30 Tech Transfers for early phase and commercial GMO biological products. 

Gerry is an active Leadership member for several industry bodies including being a Board member for PDA Australia, ISPE Australasia and ISCT Legal and Regulatory Affairs ANZ. Gerry is also a member of the TGA Industry Working Group on Good Manufacturing Practices (TIWGG).  

 Previous Industry Roles have included:  

  • 7 years as Executive lead for Quality for Cell Therapies Pty Ltd, with accountability for QA, QC, Validation, Regulatory Affairs, EH&S and Information Security across clinical trial and commercial manufacturing facilities and the Peter MacCallum Cancer Centre for cell collection and cryopreservation. Within this role Gerry also devised and executed the CTPL digitisation strategy which included the transition from paper to the implementation of an MES platform with Augmented Reality functionality and using Virtual Reality as part of training delivery. 
  • 4 years with APAC Quality accountability for Zoetis R&D covering pilot manufacturing plants for vaccines in Australia and Beijing and oversight for clinical trials in the APAC region. 
  • 4 years with Universal Biosensors with Quality responsibility for R&D of medical device hardware and software development and clinical trials being conducted in Australia and the US. 
  • Previous roles involved laboratory leadership roles for Catalent, GSK and Boston Scientific with accountability for operational, stability, method development and validation programs. 

Areas of Expetise

  • Regulatory Compliance for TGA, PMDA, MFDS, TFDA, SFDA, HKDH, PIC/S, FDA, OGTR, DAFF, APVMA
  • Lead auditor and experienced audit host
  • New Facility Commissioning Plans and Accreditation
  • Tech Transfer Strategy and Project Management
  • Cell, gene and tissue therapy products

Examples of Projects Executed

  • QMS and Facility Operations Establishment Car-T Manufacturing Facility, China
  • QMS Implementation for a Cell and Gene Therapy CDMO in Japan
  • Manufacturing License Strategy and Execution for Commercial Supply of Car-T's for Australia, Japan, Rep. of Korea, Hong Kong, Singapore and Taiwan
  • Over 30 Tech Transfer Projects for Clinical Trial and Commercial Cell and Gene Therapy Products for T-Cell's, NK Cell's, iPSC Cell's, Stem Cells
  • Digitization Strategy, Business Case Compilation and Project Execution for MES Deployment with Augmented Reality Functionality