Michael Ambrose is the Vice President of Lab and Manufacturing Services and Solutions at USDM Life Sciences.
Michael brings over 33 years of life sciences industry experience, specializing in IT and GxP compliance consulting (13 years industry, 20 years as a consultant), focused on delivery of practical and efficient IT solutions and compliance initiatives at the department, site and global level.
Prior to joining USDM, he was with EMC for 5 years as the Practice Manager, Life Sciences Compliance and Risk Management providing IT risk and quality management services and solutions.
Skills include the development and execution of strategic compliance programs, infrastructure qualification, computerized system validation, implementation of quality systems, and organizational assessments/auditing for conformance with CSV best practices and regulatory requirements.
Areas of expertise include:
- Development and execution of CSV compliance and remediation programs
- Computer validation
- Quality management and auditing
- Organizational development/coaching