Marc Twitty
Director of Quality Assurance, Pharmaceutical Development Services
Marc Twitty is the Smithers Pharmaceutical Development Services Division Director of Quality Assurance (QA) responsible for the QA Units located at both the Gaithersburg, Maryland and Ewing, New Jersey locations. Marc has over three decades of experience within the non-clinical regulated industry and Quality Assurance. He has conducted non-clinical GLP-regulated safety assessment studies, performed as an auditor, and brought this knowledge into the development, refinement, and growth of several QA Units (QAU) and staff. His experience spans both Sponsor and Contract Research Organizations supporting international (US, OECD, Asia) regulatory agencies.
Throughout his career, Marc has held QAU leadership roles of increasing responsibility and brings extensive Quality Assurance management experience to Smithers PDS LLC. He has implemented risk-based compliance programs and monitored regulatory compliance for effectiveness and operational performance through key performance and quality indicators. He is responsible for managing the daily operations of the Quality Assurance Unit which encompasses, in part, scheduling of work assignments, overseeing quality assurance records, reviewing audit reports, and assuring regulatory compliance. Additional responsibilities include hosting regulatory agency and client compliance assessment inspections, administration of the GLP training program, and QA oversight for GLP computer system and method validation efforts. Currently, Marc oversees six QAU staff members.
The QAU ensures technical functions performed in support of regulated laboratory studies conducted at Smithers PDS LLC comply with applicable GLPs, GCLP Standards, FDA and EMEA Guidance Documents, study protocols, analytical plans, bioanalytical methods, and company SOPs. Marc received his B.A. and M.A. degrees from Fairleigh Dickinson University. He is a member of the Society of Quality Assurance (SQA), the Mid-Atlantic Region SQA, the Pacific Region SQA, the SQA GLP Specialty Section, and the Research.
Throughout his career, Marc has held QAU leadership roles of increasing responsibility and brings extensive Quality Assurance management experience to Smithers PDS LLC. He has implemented risk-based compliance programs and monitored regulatory compliance for effectiveness and operational performance through key performance and quality indicators. He is responsible for managing the daily operations of the Quality Assurance Unit which encompasses, in part, scheduling of work assignments, overseeing quality assurance records, reviewing audit reports, and assuring regulatory compliance. Additional responsibilities include hosting regulatory agency and client compliance assessment inspections, administration of the GLP training program, and QA oversight for GLP computer system and method validation efforts. Currently, Marc oversees six QAU staff members.
The QAU ensures technical functions performed in support of regulated laboratory studies conducted at Smithers PDS LLC comply with applicable GLPs, GCLP Standards, FDA and EMEA Guidance Documents, study protocols, analytical plans, bioanalytical methods, and company SOPs. Marc received his B.A. and M.A. degrees from Fairleigh Dickinson University. He is a member of the Society of Quality Assurance (SQA), the Mid-Atlantic Region SQA, the Pacific Region SQA, the SQA GLP Specialty Section, and the Research.