30+ years of Quality Management experience in a manufacturing environment, with a concentration in the pharmaceutical, biologics, medical device, in vitro diagnostic, and clinical research industries.Strong knowledge of current GMPs, GLPs, and GCPs including FDA quality system regulations (specifically 21 CFR Parts 210, 211, 820, 58, & 11) as well as ISO 13485, ISO 17025.Experience in managing quality departments at multiple North American sites.Experience in various 21 CFR Part 11 compliant quality management (TrackWise), document management (MasterControl, Documentum, PTC Windchill), and training management systems (ComplianceWire).Excellent verbal and written communication skills including additional training in the following: statistical process control, project management, root cause analysis, the entire Microsoft Office suite, Microsoft Project, Microsoft Visio, and Microsoft SharePoint.Extensive experience in the planning, development, and management of quality management systems with a record of consistent achievement in improving quality, efficiency, and accountability.Experience in managing multiple quality departments at multiple sites/locations.Member of the American Society of Quality (ASQ) possessing an innate knowledge of the Quality process with proven ability to train, motivate and mentor staff members.Proficient in working in a fast paced, multidisciplinary, team based environment.Specialties: cGMPs, cGLPs, and cGCPs including FDA quality system regulations.(specifically 21 CFR Parts 210, 211, 820, 58, 11, & ISO 13485)