Associate Director, R&D Quality Regulatory & Risk Integration

Job DescriptionGeneral Position SummaryThe 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 ResponsibilitiesRegulatory Intelligence & Surveillance Process LeadershipEstablish, implement, and continuously mature the RDQ Regulatory Intelligence & Surveillance process and operating modelEnsure alignment and connectivity with enterprise/global Regulatory Intelligence & Surveillance processes and governanceDefine and maintain RI&S intake, triage, escalation, impact assessment, and governance integration pathwaysDevelop sustainable processes for identifying, evaluating, and operationalizing emerging regulatory intelligence within RDQMaintain oversight of regulatory intelligence governance activities, deliverables, and reporting mechanismsQuality Risk Management IntegrationTranslate external regulatory intelligence and surveillance signals into actionable RDQ quality risk insights and recommendationsFacilitate risk-based evaluation of emerging regulatory expectations and potential impact to RDQ processes, systems, and operationsIntegrate regulatory intelligence into RDQ quality risk management activities and governance forumsPartner with stakeholders to assess and escalate significant regulatory or inspection-related risks as appropriateSupport development of proactive mitigation and readiness strategies based on emerging regulatory trendsGovernance & Leadership EngagementServe as the Quality System Owner and RDQ representative for Regulatory Intelligence & Surveillance governance activitiesRepresent RI&S within RDQ governance forums including RDQ QLT, QMR, Monthly Risk Review Forum, and operational governance meetingsDevelop executive-level summaries, trend analyses, and risk insights for leadership review and decision-makingSupport integration of RI&S into broader RDQ governance and operating model initiativesCross-Functional Collaboration & Stakeholder EngagementServe as the RDQ Regulatory Intelligence Champion (RIC) within enterprise RI&S forums and Centers of ExcellenceBuild strong partnerships with Quality, Clinical Development, Regulatory Affairs, Global Quality Systems, Inspection Readiness, and other cross-functional stakeholdersPartner with business functions to support interpretation and operationalization of evolving regulatory expectationsFacilitate alignment between enterprise intelligence activities and RDQ operational prioritiesPartner with Regulatory Affairs to provide proactive, trusted quality support to enable high-quality execution of day-to-day operationsInspection Readiness & SurveillanceMonitor and assess inspection trends, enforcement actions, health authority focus areas, and evolving industry expectationsSupport proactive inspection readiness efforts through intelligence-driven risk identification and governance integrationIdentify emerging themes and systemic trends that may impact RDQ compliance posture or operational effectivenessSupport Regulatory Affairs, as needed, in preparing for regulatory inspections (e.g., FDA BIMO inspections)QualificationsRequiredBachelor’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 industryStrong knowledge of GxP regulations, inspection readiness principles, and quality management systemsExperience supporting or participating in governance forums and cross-functional initiativesDemonstrated ability to translate complex regulatory information into actionable business or quality insightsStrong stakeholder engagement, facilitation, and communication skillsExperience influencing across matrixed organizationsPreferredAdvanced degree (MS, PharmD, PhD, MBA, etc.)Experience with Regulatory Intelligence & Surveillance programs or governanceExperience with Quality Risk Management methodologies and risk governanceFamiliarity with ICH E6(R3), inspection trends, and emerging global regulatory expectationsExperience supporting enterprise or cross-functional transformation initiativesPay Range:$160,600 - $240,800Disclosure Statement:The range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting. This role is eligible for an annual bonus and annual equity awards. Some roles may also be eligible for overtime pay, in accordance with federal and state requirements. Actual base salary pay will be based on a number of factors, including skills, competencies, experience, and other job-related factors permitted by law.At Vertex, our Total Rewards offerings also include inclusive market-leading benefits to meet our employees wherever they are in their career, financial, family and wellbeing journey while providing flexibility and resources to support their growth and aspirations. From medical, dental and vision benefits to generous paid time off (including a week-long company shutdown in the Summer and the Winter), educational assistance programs including student loan repayment, a generous commuting subsidy, matching charitable donations, 401(k) and so much more.Flex Designation:Hybrid-Eligible Or On-Site EligibleFlex Eligibility Status:In this Hybrid-Eligible role, you can choose to be designated as:1. Hybrid : work remotely up to two days per week; or select2. On-Site : work five days per week on-site with ad hoc flexibility.Note: The Flex status for this position is subject to Vertex’s Policy on Flex @ Vertex Program and may be changed at any time.#LI-HybridCompany InformationVertex is a global biotechnology company that invests in scientific innovation.Vertex is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, sex, gender identity or expression, age, religion, national origin, ancestry, ethnicity, disability, veteran status, genetic information, sexual orientation, marital status, or any characteristic protected under applicable law. Vertex is an E-Verify Employer in the United States. Vertex will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law.Any applicant requiring an accommodation in connection with the hiring process and/or to perform the essential functions of the position for which the applicant has applied should make a request to the recruiter or hiring manager, or contact Talent Acquisition at View email address on click.appcast.io #J-18808-Ljbffr