Jason Donnelly

Jason Donnelly has extensive experience in quality assurance and compliance within the pharmaceutical industry. Jason has held various leadership roles at different companies, including Scholar Rock, Vertex Pharmaceuticals, Merrimack, Genocea Biosciences, sanofi pasteur, and Acambis.

At Scholar Rock, they currently serve as the Senior Director of Clinical and Quality Compliance. Prior to this, they held the role of Director of Clinical and Quality Compliance.

At Vertex Pharmaceuticals, Jason worked as the Senior Quality Manager in R&D QA. Their responsibilities included managing the GCP vendor audit schedule, coordinating with auditing consultants and internal teams, reviewing audit reports, and implementing corrective actions.

At Merrimack, they were the Associate Director of QA. Jason played a key role in building Clinical Quality Systems, developing Clinical Quality Plans, and conducting audits of clinical investigator sites, CROs, and study documents.

At Genocea Biosciences, Jason served as an Associate Director of QA. Jason was responsible for developing cGxP Quality Systems, providing GxP support for development programs, and managing compliance aspects of partnerships with contracted facilities.

During their time at sanofi pasteur, they held the position of R&D QA Manager. Jason oversaw all QA cGxP activities, including review of manufacturing documents, processing deviations and CAPA, audit scheduling, and ensuring quality agreements with vendors.

At Acambis, Jason worked as a QA Manager before joining sanofi pasteur.

Overall, Jason Donnelly has demonstrated expertise in quality assurance, compliance, auditing, and developing quality systems within the pharmaceutical industry.

Jason Donnelly received their Master's Degree in Drug Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Health Sciences. Jason attended the college from 2004 to 2006.