Credentials

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Credentials

Experienced Practitioner:

– Over 45 years’ experience in biopharma and medical devices; most at an executive level.
– Experienced in sterile manufacture, complex pharmaceutical production and non-sterile products.
– Managed quality, regulatory, R&D, operations, customer service, and supply chain and compliance in Australia & New    Zealand, Asia Pacific, Europe and the United States.
– Implemented quality management systems and compliance programs in Australia & New Zealand, Asia Pacific, Europe and United States.

Accomplished Manager:

– Past General Manger of a high-volume, specialized sterile facility in Australia.
– Past Vice President positions in the United States, Senior Director across Asia Pacific, Chief Operating Officer of a medical device company and Managing Director and Chief Executive Officer of a public biotech.
– Managed all technical areas of pharma and medical devices – Quality, Compliance, Integrity, R & D, Regulatory Affairs.

Industry Involvement:

– Lectured Good Manufacturing Practice to the Hanoi School of Pharmacy.
– Previous Advisor to the Australian Department of Industry & Resource on Biotechnology policies,
– Previous Committee member for
       *  AusBiotech the Australian Pharmaceutical Manufacturer’s Association
       *  West Australian Chamber of Commerce & Industry,- Previous member of:
       *  European Pharmaceutical Manufacturer’s Association Technical Committee, International Trade, 
       *  International Federation Pharmaceutical Manufacturers & Associations Code revision committee,
       *  Medicines Australia Code of Conduct revision committee.
– Past Chairman of the Cosmetic & Pharmaceutical Special Interest Group of the Australian Society for Microbiology.
– Member of the Society of Corporate Compliance and Ethics; American Society of Quality and Health Care Compliance Association.

Peer Recognition:

– Recipient of the George Varkanis (Celgene ANZ) Leadership Award in 2018.
– Invited speaker at over twelve international conferences.
– Over 50 published articles on quality, compliance, ethics, training, reward & recognition, and integrity.
– Calvin is a certified International with the International Association of Professional Writers & Editors (IAPWE).