Root Validation Services

Thirty-plus years of experience in Life Sciences. 25+ years experience in various computer systems validation and quality roles. Expertly skilled in system life cycle document authoring, change control, and document review/critique. Proven leadership and mentoring abilities. Proficient in assessing and auditing documents, procedures, and policies. Employer/client engagements include: Cellular Products, Inc., OrthoClinical Diagnostics, McNeil, Merck, Osteotech, SmithKline Beecham, Johnson & Johnson PRD, URL-Mutual, RWJ-PRI/Janssen, ConvaTec, Amgen, Beaufour-Ipsen, Schering-Plough, Cordis, AstraZeneca, Wyeth, ICON, GlaxoSmithKline, Celgene/BristolMyers Squibb, PTC Therapeutics, and Frontage Labs.