09 July 2010 - Almac’s Clinical Technologies division announced today that Bill Kane has joined the company as Director of Quality Assurance (QA) and Regulatory Compliance. He will head Almac’s QA & Compliance department and will be responsible for supporting internal, client, and agency audits, as well as improving internal Quality and Compliance programs.
With 30 years of overall experience, Mr. Kane has more than 10 years of experience in the biopharmaceutical industry and an additional 5 years supporting toxicological laboratories. He has served in a variety of capacities involving management of GxP compliance, computer systems validation, system development lifecycle (SDLC) process controls, Information Security Programs, Sarbanes Oxley compliance, and Records Management programs.
Mr. Kane joins Almac after spending 10 years at Johnson and Johnson’s (J&J) Pharmaceutical Supply Chain organization as a Global Information Technology Director, Compliance & Quality Systems. At J&J, Mr. Kane was responsible for Information Technology (IT) compliance for Centocor Ortho Biotech, Tibotec, the Global Pharmaceutical Sourcing Group (GBSC IT), and the Global Biopharm Supply Chain organization. As Global Information Technology Director, Mr. Kane led a team of regional compliance experts in supporting a global supply chain business in a uniform and compliant manner. He was also responsible for the global deployment of a uniform SDLC inside J&J’s Pharmaceuticals business unit.
Jim Murphy, President of Clinical Technologies comments on Mr. Kane’s appointment: “We are very pleased that Bill Kane has joined Almac. He brings a tremendous amount of industry experience to our firm that will help Almac with the development and application of process excellence tools to identify and correct quality issues more rapidly while streamlining development efforts. Given his background in both cGMP and cGCP compliance, Bill will be particularly valuable in supporting Almac’s integrated technology and drug supply management service offering.”
Mr. Kane has a B.S. Biology degree from Indiana University of Pennsylvania and an M.B.A. in Management of Information Systems from Temple University. He is a certified Six-Sigma green belt and is certified in Computer Systems Validation.
About Almac Group
The Almac Group comprises five closely integrated divisions offering a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.
The company employs over 2,700 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California. Construction of the company’s new $120m North American Headquarters started in July 2008 and will be completed 2010.
Almac Clinical Technologies division specializes in interactive technology and service solutions to increase the quality and efficiency of the clinical trial process. Our solutions include Interactive Voice and Web Response Systems (IXRS™) for patient randomization, tracking and clinical supply management; electronic patient reported outcomes data collection; and Web drug reconciliation. Almac’s technologies have been deployed in over 1450 clinical trials, incorporating over 1.5 million patients in over 80 countries and more than 60 languages.
For more information about the Almac Group, please visit www.almacgroup.com or e-mail firstname.lastname@example.org.
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