Vertex
Biotechnology
AssociateDirector,R&DQualityRegulatory&RiskIntegration
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“Associate Director, R&D Quality Regulatory & Risk Integration at Vertex. Skills: Regulatory Intelligence, Quality Risk Management, Governance. Establish Regulatory Intelligence & Surveillance process. Implement Regulatory Intelligence & Surveillance process”
Industry & Context.
Root cause analysis; Risk assessment
What They're Looking For.
Must Have
Bachelor's degree in Life Sciences, 8+ years of experience in Quality, Regulatory Affairs, Regulatory Intelligence, Quality Risk Management, Clinical Quality, or related GxP functions, knowledge of GxP regulations, knowledge of inspection readiness principles, knowledge of quality management systems, Experience supporting governance forums, Experience participating in cross-functional initiatives, Demonstrated ability to translate complex regulatory information into actionable business or quality insights, stakeholder engagement skills, facilitation skills, communication skills, Experience influencing across matrixed organizations
Nice to Have
Advanced degree (MS, PharmD, PhD, MBA, etc.), Experience with Regulatory Intelligence & Surveillance programs, Experience with governance, Experience with Quality Risk Management methodologies, Experience with risk governance, Familiarity with ICH E6(R3), Familiarity with inspection trends, Familiarity with emerging global regulatory expectations, Experience supporting enterprise transformation initiatives, Experience supporting cross-functional transformation initiatives
What You'll Do.
Establish Regulatory Intelligence & Surveillance process
Implement Regulatory Intelligence & Surveillance process
Mature Regulatory Intelligence & Surveillance process
Ensure alignment with enterprise RI&S processes
Define RI&S intake pathways
Define RI&S triage pathways
Define RI&S escalation pathways
Define RI&S impact assessment pathways
Define RI&S governance integration pathways
Develop processes for identifying regulatory intelligence
Develop processes for evaluating regulatory intelligence
Develop processes for operationalizing regulatory intelligence
Maintain oversight of regulatory intelligence governance
Translate external regulatory intelligence into insights
Translate external regulatory intelligence into recommendations
Facilitate risk-based evaluation of regulatory expectations
Integrate regulatory intelligence into risk management
Integrate regulatory intelligence into governance forums
Partner with stakeholders to assess risks
Partner with stakeholders to escalate risks
Support development of mitigation strategies
Support development of readiness strategies
Serve as Quality System Owner for RI&S
Represent RI&S within RDQ governance forums
Develop executive-level summaries
Develop trend analyses
Develop risk insights for leadership
Support integration of RI&S into RDQ governance
Support integration of RI&S into RDQ operating model
Serve as RDQ Regulatory Intelligence Champion
Build partnerships with Quality
Build partnerships with Clinical Development
Build partnerships with Regulatory Affairs
Build partnerships with Global Quality Systems
Build partnerships with Inspection Readiness
Partner with business functions to support interpretation
Partner with business functions to support operationalization
Facilitate alignment between intelligence activities and priorities
Provide quality support to Regulatory Affairs
Monitor inspection trends
Assess inspection trends
Monitor enforcement actions
Assess enforcement actions
Monitor health authority focus areas
Assess health authority focus areas
Monitor evolving industry expectations
Assess evolving industry expectations
Support proactive inspection readiness efforts
Identify emerging themes impacting compliance
Identify systemic trends impacting compliance
Support Regulatory Affairs in preparing for inspections
How You'll Work.
Team & Collaboration
Cross-functional stakeholders; Enterprise RI&S forums; Quality System Owners; Regulatory Affairs; Global Quality Systems; Inspection Readiness
Communication Scope
Executive summaries; Trend analysis; Risk insights
Process & Methodology
Governance, Process improvement
Full Job Description
**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 Regulat
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