The Associate Director, R&D Quality Regulatory & Risk Integration is responsible for establishing, implementing, and maturing the R&D Quality Regulatory Intelligence & Surveillance (RI&S) process within RDQ and serving as the main quality point of contact for Regulatory Affairs. This role serves as the strategic integration point between external regulatory intelligence, proactive quality risk management, governance processes, and inspection readiness activities across R&D Quality.
The role partners closely with Global Regulatory Intelligence & Surveillance functions, RDQ leadership, Quality System Owners, Regulatory Affairs, and other cross-functional stakeholders to ensure emerging regulatory expectations, inspection trends, enforcement actions, and industry signals are proactively translated into actionable RDQ risk, governance, and operational activities.
This individual will serve as the RDQ Regulatory Intelligence Champion (RIC) within enterprise Regulatory Intelligence forums and Centers of Excellence and will represent the Regulatory Intelligence Quality System within RDQ governance forums including the RDQ Quality Leadership Team (QLT), Quality Management Review (QMR), Monthly Risk Review Forum, and operational governance meetings.
The Associate Director will serve as a quality business partner to Regulatory Affairs functions and be the resource for quality consults, process improvement initiatives, quality events, and inspection readiness activities.
This position sits within the R&D Governance & Risk Management organization and plays a key role in advancing proactive, risk-based governance and inspection readiness capabilities across RDQ.
Vertex is a global biotechnology company that invests in scientific innovation to create transformative medicines for people with serious diseases and has made significant advancements in cystic fibrosis, sickle cell disease, transfusion-dependent beta thalassemia, and acute pain — and continues to progress clinical and research programs in these diseases. We also have a robust clinical pipeline of investigational therapies across a range of modalities in other serious diseases where we have deep insight into causal human biology, including acute and neuropathic pain, APOL1-mediated kidney disease, IgA nephropathy, autosomal dominant polycystic kidney disease, type 1 diabetes and myotonic dystrophy type 1. Our global headquarters is in Boston, and we have research and development (R&D) sites and commercial offices worldwide. Vertex is consistently recognized as one of the industry’s top places to work by Science Magazine, The Boston Globe, Boston Business Journal and the San Diego Business Journal. We have also earned a spot on TIME Most Influential Companies, TIME Best Inventions, and Fast Company Most Innovative Companies lists. Our research and medicines have received esteemed recognitions, including the Robert J. Beall Therapeutics Development Award, the Prix Galien, the Scrip Award and the Breakthrough Prize awards. Read our community guidelines: https://www.vrtx.com/vertexs-community-guidelines/
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