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Meet the Subject Matter Experts Leading Our Team

Michael Ambrose is the Vice President of Lab and Manufacturing Services and Solutions at USDM Life Sciences.   Michael brings over 30 years of life science experience that includes 13 years in the pharmaceutical industry including roles managing a toxicology laboratory and clinical trials operations.
David Blewitt is the Vice President of Cloud Compliance at USDM Life Sciences. David is an accomplished Life Sciences Regulatory and IS Compliance Professional with extensive hands-on and leadership experience in the Pharmaceutical, Medical Device, Biotech and Blood Management Industries, specifically in the fields of; Computer Systems Validation, Risk Management, Issue Investigation – Root Cause Analysis and Remediation, Quality Assurance, Software Development Lifecycle, Lean IS Compliance Enhancement Initiatives, Business Analysis, Product Lifecycle Management and Systems/Process analysis with Compliance Roadmap development.
Holger Braemer is the Vice President USDM Europe at USDM Life Sciences.  Holger is the primary commercial manager within the USDM European team and the newly founded USDM Europe GmbH in Germany.  He is based in Germany and USDM’s primary contact for all European Customers, Partners and Employees.
Jay Crowley is the Vice President of the Unique Device Identification Services and Solutions at USDM Life Sciences. Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s Unique Device Identification system.
Diane Gleinser is the Senior Vice President of Life Science Services and Solutions at USDM Life Sciences. Diane 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.
Hussam Kazi is the Head of Delivery and Project Management at USDM Life Sciences.  Hussam brings extensive biotechnology experience to USDM, including 22 years of leadership in managing and deploying global enterprise wide solutions in a regulated environment.
Bob Lucchesi is the Vice President of Global Regulatory Compliance, Quality Assurance and Auditing at USDM Life Sciences. His expertise extends to several USDM Life Sciences practice areas, including Enterprise Quality Management, Enterprise Content Management, Quality Management Systems, and Governance, Risk and Compliance.
Jim Macdonell is the Vice President of Medical Device Services and Solutions at USDM Life Sciences.  He is an experienced consulting manager with over 20 years of defining client program needs and building and managing implementation teams.
Brian McCole is the Director of the Enterprise Quality Management Services and Solutions at USDM Life Sciences. Brian is a highly experienced professional with a 20 year IT implementation track record. His experience includes 15 years of developing and supporting Quality Management System programs and 10 years of managing Enterprise Resource Planning system programs. He also has experience with business process improvement, regulatory compliance and the governance supporting technologies in the life sciences industry. Most recently, Brian was a Director of Quality/CAPA Systems and Compliance where he created a global quality system for one of the largest bio-pharmaceutical manufacturers in…
Erin Northington is the Vice President of Emerging LIfe Sciences and Clinical Solutions at USDM Life Sciences. Erin has two decades of experience in Clinical Applications, Business Relationship Management and Project Management. She also has a background in GCP compliance, vendor evaluation and management, systems validation and implementations, as well as process evaluation and improvement. She specializes in managing global enterprise-wide IT implementations of technology solutions. Her wide-ranging life sciences experience includes managing customer relationships for assigned business units, direct line management, strategic planning, product and applications.
Subbu Viswanathan is the Head of Solutions at USDM Life Sciences. He has more than 20 years of technology, software development, infrastructure, virtualization, validation, and compliance experience focused on the life sciences industry.
Manu Vohra is the Vice President of Enterprise Content Management Services and Solutions at USDM Life Sciences. He is a seasoned professional with two decades under his belt deploying content management solutions for Life Sciences while running operations within several IT functions supporting Drug Discovery to Commercialization. He specializes in guiding Biopharmaceuticals in developing long term content management strategies by applying Digital Transformation principles and technologies.
Michael Canale is the Vice President of Compliance Wellness at USDM Life Sciences.


  • Clintrak - Jeffrey D. Coffin
    I have had the great pleasure to work with Bob for 5 years in his position of VP of Quality at Fisher Packaging Services while I acted as Director of Quality services at a sister…
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