Associate Director, R&D Quality Regulatory & Risk Integration

Job Description General Position Summary 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.

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 RDQMaintain 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

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

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)
Qualifications Required Bachelor ’s degree in Life Sciences or related discipline8+ 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…