Quality Assurance & Compliance
Cynthia McCants has been a Quality and Compliance leader with over 26 years of international and domestic experience. She has had roles in commercial quality, manufacturing, clinical and preclinical drug development, drug safety, auditing, regulatory compliance and supplier quality. Her core areas of expertise are QA Strategic Planning and Execution, Corporate Change Management, Development and Implementation of Auditing tools in cGMP Environments, In-License Acquisitions, Regulatory Inspection Management, External Supplier Organizations, Contract Research Organizations, Contract Manufacturing Organizations, Risk Management and Mitigation, Building, Coaching and Developing Teams, Regulatory Compliance (FDA, CFIA, USDA, Health Canada, MAPA, ICA, AFSSA, WHO, MHRA, EMA, ANVISA, and SAG) and is a Qualified Compliance Auditor with 16 years of auditing experience.
Throughout her career, she has had in depth experience with integrating quality systems for due diligence, in-licensing and strategic alliance collaborations. Her roles have required her to effectively interface with corporate executives, stakeholders and partners and influence across diverse networks to facilitate the achievement of business needs as well as influence regulatory authorities during inspections and responded to quality compliance issues successfully.
She has experience in solid dosage, sterile, topical, soft gel, parenteral, suspension, vaccine and liquid final drug dosage forms and has 15 years of quality assurance management experience for GCP, GLP, and cGMP operations, 13 years of Clinical Operations experience as a scientist, auditor and operations manager and 16 years auditing experience, 10 years of which as a Qualified Compliance Auditor for Novartis.
Cynthia was the Head of Quality Operations for North and Latin America for the Novartis Corporation and held a key role in the integration process of the Novartis Animal Health acquisition by Elanco, a division of Eli Lilly. She also held other leadership roles at Novartis as the Director, Global Quality Clinical Operations, the Global Compliance Manager, Regulatory Compliance Manager and Senior Regulatory Compliance Auditor at Novartis. She also spent a number of years at Bayer Pharmaceutical Corporation as a Compliance Investigator and a Laboratory Compliance Manager. In her early years at Bayer she was a Technical Lead Scientist and a Clinical Laboratory Supervisor. At Duke University Medical Center she was a Project Coordinator where she acted as the liaison between Duke University Medical Center and the National Institute of Environmental Health Sciences for research projects she oversaw.
Cynthia is frequently asked to speak at the College of Agriculture and Life Science at North Carolina State University and was on the Motivational Task Force for the Office of Alumni Relations at North Carolina Central University. She was also the Founder and Sponsor of the first Employee Resource Group (ERG) in Novartis Consumer Health called EMBRACE.
Cynthia McCants is a Babson College Executive Program Graduate for Developing and Implementing Corporate Strategy, a Novartis Corporation Master's Program Graduate and holds a Bachelor of Science in Biology and Chemistry from North Carolina Central University.
For more information visit: https://www.linkedin.com/in/cmccantsqleader/
Hughes CL, Kaldas RS, Weisinger AS, McCants CE, Basham KB. Acute and subacute effects of naturally occurring estrogens on luteinizing hormone secretion in the ovariectomized rat: Part I. Reprod Toxicol,1991; 5:127-132.