Roy Sturgeon, Ph.D.
Roy began his career at Lachman Consultants as Executive Vice President of the Compliance Practice. He progressed to the position of President and became a Senior Advisor and Outside Director to the Board after retirement. In his current role he provides analyses of the strategic plans and oversight of the strategic initiatives and objectives of the firm in addition to chairing the Board of Directors. Dr. Sturgeon is an expert in crisis management, having handled product withdrawals, and Class I, II, and III recalls, and has served as Corporate Crisis Manager at several large Pharmaceutical Companies. He is proficient in negotiating and responding to global regulatory inspections and in creating detailed plans for remediations. Dr. Sturgeon assessed and evaluated complex development, manufacturing, and compliance issues to provide the appropriate regulatory guidance and resources in the manufacture of pharmaceuticals (all dosage forms), biologicals, dietary supplements, vaccines, animal health products, infant formula, devices and diagnostics. He led efforts for regulatory compliance assessments for M&A projects.
- Oversight of development / implementation of global Quality Systems strategies
- Provide Board-level advice to Senior Executives at Client Firms
- Assist firms on regulatory matters related to consent decree negotiations and resolution, application integrity policy audits, technology transfer, due diligence for M&A projects including product and company acquisitions
- Oversight of remediation and compliance enhancement programs
- Oversight of the technical aspects for consent decree activities, including development of work plans
- Oversight of product quality assessments to evaluate product data
- Oversight of the development, formulation, manufacturing, quality, and technical manufacturing strategies, and compliance enhancements
- Provide training on compliance issues
- Oversight of validity assessments (data integrity)
- Management of GMP, GCP, GLP, biopharmaceuticals pre-approval audits
- Provide subject matter expertise in product development, formulation/manufacturing issues and product launches
- Lachman Consultant Services, Inc.
- Interim Chairman of the Board
- Senior Advisor, Outside Director to the Board
- The Quantic Group, Ltd.
- Vice President and Managing Director
- Senior Vice President, Global Technology
- Senior Vice President, Quality Assurance
- Vice President, Global Quality Operations
- Merck and Company
- Various Senior Management Positions in Quality, Technical Services and Manufacturing
- American McGaw Laboratories
- Senior Staff Research Scientist, Formulation
- University of South Carolina
- Assistant Professor, Department of Pharmaceutics
- Universities of Florida and Kentucky
- D., Pharmaceutical Sciences/Analytical Chemistry – University of Florida
- S. Pharmacy – University of Florida
- A. Chemistry – University of Florida