Theresa Donegan M.S.

Theresa Donegan M.S. has over twenty years of experience in Quality Assurance roles. In 1992, they began their career as a Lead Analytical Chemist and Research Assistant at Tektagen Inc (currently Charles River Biopharmaceutical Services). In 1996, they moved to SmithKline Beecham (now GlaxoSmithKline) as a Quality Control Biochemist. During their time there, they developed and implemented a raw material supplier inspection program, performed analytical testing for product release, in-process, drug substance and stability, and was responsible for deviations and CAPA. In 1998, they became a Compliance Specialist at SmithKline Beecham/GlaxoSmithKline, where they performed audits of nonclinical facilities and analytical laboratories to access compliance with company procedures and appropriate domestic and international regulations. Theresa then moved to Donegan Consulting in 2000 as a GLP QA Consultant, where they provided quality assurance, vendor and CRO quality assessment, critical phases, data, reports, computerized systems validation and general compliance consulting. In 2004, they joined Charles River Laboratories as a Senior Specialist - Global Computer Systems Validation QA and Manager Regulatory Compliance -PCS-MA, where they managed all Quality Assurance internal and external staff and regulatory compliance workload, developed the growth of the Quality Assurance Unit from 8 QA professionals to 18 QA professionals, and managed the audit program including facilities, vendors, documentation and processes for compliance. In 2012, they returned to Donegan Consulting as a Quality Assurance Consultant, where they evaluated preclinical facilities and laboratories for compliance with GLP, GCP, and CLIA compliance, designed and implemented GLP Quality Assurance Unit Compliance Programs, audited safety assessment studies, preclinical and clinical bioanalytical and toxicokinetic data, study phase inspections and process inspections, and more. In 2018, they became the Head Of Quality Assurance at MERRIMACK PHARMACEUTICALS U.K. LIMITED, where they ensured compliance with applicable external regulations and standards, ensured compliance to internal policies and procedures, and ensured oversight of CMOs manufacturing drug on behalf of Merrimack including testing, release. In 2019, they joined Rubius Therapeutics as a Senior Director Quality Assurance, where they established Corporate QA organization during pandemic and grew to 7 FTE over approximately 3 years managing a ~4 M budget within 10% of target with zero staff attrition, established Corporate Quality Assurance Unit including Quality Systems, QA Compliance, R&D Compliance and CMC QA functions in Phase I/II biotech producing novel allogenic cell therapy, and ensured phase appropriate compliant regulated operations (cGMP, GLP, GCP, GTP) utilizing both FTE and consulting resources as needed based on program development and company financing. Most recently, in 2022, they joined Clade Therapeutics as an Executive Director Quality Assurance.

Theresa Donegan M.S. obtained a B.S. in Biochemistry from the University of the Sciences in Philadelphia, followed by an M.S. in Quality Assurance/Regulatory Affairs from Temple University.