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Meet Jayne Gill –Managing Director, Life Sciences Consulting Jayne joined USDM earlier this year and has continued to successfully grow and drive our USDM Consulting Division. She is responsible for the continuous improvement and acceleration of how USDM delivers specialized talent and consulting services. Jayne has had a successful career with over 25 years’ experience in global consulting services, and over 15 years in Life Sciences where she has built and grown consulting and staffing companies. That experience, coupled with her hands on approach has made Jayne a perfect addition to the USDM family!
Meet John Michael Petrakis – USDM Vice President of Clinical and Safety Services. John has over 30 years of diverse global industry experience in business transformation, delivering solutions that addressed regulatory and quality pressures, resource constraints, new and growing markets, system integration and optimization of global operations. John joined USDM in 11/2018 and has come on as our Vice President of Clinical and Safety Service and is Head of the Cloud Assurance Business Unit. It is John’s goal to drive Cloud Assurance to a new level of Managed Services to drive our annuity growth agenda benefiting both USDM and its global clients. John has led all aspects of strategy development and delivered value for pharmaceutical, biotech, medical device, and healthcare companies through customer-centric solutions, e.g., application development and maintenance, ERP, digital/analytics, cybersecurity, cloud, intelligent automation, quality & compliance, pharmacovigilance (Pv), organizational change management.
Meet Erin Christy – Erin is USDMs VP of Emerging Life Sciences and Clinical Practice. The Emerging Life Sciences team was developed and kicked off their journey with USDM in the beginning of 2017 after recognizing the needs of Emerging Life Science companies are all similar to each other, but very different from the bigger, more established companies. Our skillful Emerging team helps companies that are pre-commercial, newly commercialized, or existing but newly entering the Life Sciences regulated space, and start-up software companies that are entering the regulated space. Erin and her team helps these companies develop their IT and Compliance Roadmaps, CSV Programs, implement their Quality Management Program, and implement technologies that will help them to become commercialized. The team does a lot of training and Organizational Change Management with these companies, helping them with IT strategies, and guide them through the compliance. It is Erin’s goals are to lead, mentor, and remove roadblocks for the Emerging team, to develop new business possibilities.
USDM Life Sciences Wins Box's 2018 Services Partner of the Year, Awarded for Innovation. On August 28th, USDM received the award at the BoxWorks Partner Summit.
Meet Diane Gleinser, Senior Vice President of Life Science Services and Solutions Diane Gleinser has more than 27 years of experience in life science based industries encompassing quality assurance, quality control, validation and regulatory compliance for research and development, clinical affairs, manufacturing and packaging, laboratory setup and analysis, and auditing under cGMP, cGLP and cGCP regulations and 21 CFR Part 11. Diane has been with USDM since 2002 and has been an integral part of USDM’s growth over the years, where she has worn a variety of hats and is now part of the USDM Executive Leadership Team. Please reach out to Diane to say hello or if you have any questions - dgleinser@usdm.com
2018 is flying by! Check out our white paper on the hottest trends in life sciences this year! http://glassdoor.com/slink.htm?key=vQIAi
Expert Diane Gleinser analyzes the FDA’s new action plan to improve medical device cybersecurity in her latest blog! Discover the FDA’s five key steps from the action plan below and register for our upcoming webinar next Thursday to learn more about how your company can improve it's cybersecurity.
Meet our Vice President of Lab and Manufacturing Services, Michael Ambrose! Michael has over 30 years of life science experience including 13 years in the pharmaceutical industry. He specializes in strategic IT and GxP compliance consulting and focuses on the delivery of practical and efficient IT solutions and compliance initiatives at the department, site, and global level.
Nearly 4 million records are stolen from security breaches every day, and that number continues to rise. We work with companies regulated by the FDA to achieve enterprise-wide and medical device compliance to help assess and mitigate the risk of Cybersecurity vulnerabilities and build in Data Integrity. Learn more about how we can help!
Meet our VP of Cloud Development / Digital Transformation Subject Matter Expert, Bryan Coddington! Bryan started his IT career right out of college in London and has been helping companies use technology to improve processes and deliver better products and services ever since. He has an in-depth knowledge of GxP processes, application, integration, and validation, helping companies maximize their investment in Cloud-based solutions.
