Associate Director, R&D Quality Regulatory & Risk Integration
Vertex Pharmaceuticals · Boston, MA · 2 wk ago
HybridInformation Technology$161k–$241k/yrFull-time
Key Responsibilities
- Regulatory Intelligence & Surveillance Process Leadership
- Establish, implement, and continuously mature the RDQ Regulatory Intelligence & Surveillance process and operating model
- Ensure alignment and connectivity with enterprise/global Regulatory Intelligence & Surveillance processes and governance
- Define and maintain RI&S intake, triage, escalation, impact assessment, and governance integration pathways
- Develop sustainable processes for identifying, evaluating, and operationalizing emerging regulatory intelligence within RDQ
- Maintain oversight of regulatory intelligence governance activities, deliverables, and reporting mechanisms
- Quality Risk Management Integration
- Translate external regulatory intelligence and surveillance signals into actionable RDQ quality risk insights and recommendations
- Facilitate risk-based evaluation of emerging regulatory expectations and potential impact to RDQ processes, systems, and operations
- Integrate regulatory intelligence into RDQ quality risk management activities and governance forums
- Partner with stakeholders to assess and escalate significant regulatory or inspection-related risks as appropriate
- Serve as the RDQ Regulatory Intelligence Champion (RIC) within enterprise RI&S forums and Centers of Excellence
- Support development of proactive mitigation and readiness strategies based on emerging regulatory trends
- Governance & Leadership Engagement
- Serve as the Quality System Owner and RDQ representative for Regulatory Intelligence & Surveillance governance activities
- Represent RI&S within RDQ governance forums including RDQ QLT, QMR, Monthly Risk Review Forum, and operational governance meetings
- Develop executive-level summaries, trend analyses, and risk insights for leadership review and decision-making
- Support integration of RI&S into broader RDQ governance and operating model initiatives
- Cross-Functional Collaboration & Stakeholder Engagement
- Serve as the RDQ Regulatory Intelligence Champion (RIC) within enterprise RI&S forums and Centers of Excellence
- Build strong partnerships with Quality, Clinical Development, Regulatory Affairs, Global Quality Systems, Inspection Readiness, and other cross-functional stakeholders
- Prioritize alignment between enterprise intelligence activities and RDQ operational priorities
- Partner with business functions to support interpretation and operationalization of evolving regulatory expectations
- Facilitate alignment between enterprise intelligence activities and RDQ operational priorities
- Partner with Regulatory Affairs to provide proactive, trusted quality support to enable high-quality execution of day-to-day operations
- Inspection Readiness & Surveillance
- Monitor and assess inspection trends, enforcement actions, health authority focus areas, and evolving industry expectations
- Support proactive inspection readiness efforts through intelligence-driven risk identification and governance integration
- Identify emerging themes and systemic trends that may impact RDQ compliance posture or operational effectiveness
- Support Regulatory Affairs, as needed, in preparing for regulatory inspections (e.g., FDA BIMO inspections)
- Bachelor’s degree in Life Sciences or related discipline
- 8+ years of experience in Quality, Regulatory Affairs, Regulatory Intelligence, Quality Risk Management, Clinical Quality, or related GxP functions within the pharmaceutical/biotechnology industry
- Strong knowledge of GxP regulations, inspection readiness principles, and quality management systems
- Demonstrated ability to translate complex regulatory information into actionable business or quality insights
- Strong stakeholder engagement, facilitation, and communication skills
- Experience influencing across matrixed organizations