Associate Director, R&D Quality Regulatory & Risk Integration
Vertex Pharmaceuticals
June 27, 2026
Remote friendly (Boston, MA)
United States
Corporate Functions
General Position Summary
Associate Director 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.
Key Responsibilities
- Establish, implement, and continuously mature the RDQ RI&S process/operating model.
- Define and maintain RI&S intake, triage, escalation, impact assessment, and governance integration.
- Translate regulatory intelligence into actionable RDQ quality risk insights, recommendations, and readiness strategies.
- Integrate RI&S into RDQ quality risk management and governance forums; assess/escalate significant regulatory/inspection risks.
- Serve as Quality System Owner and RDQ representative for RI&S governance; represent RI&S in RDQ QLT, QMR, and risk review forums.
- Develop executive summaries/trend analyses and support RI&S integration into RDQ governance initiatives.
- Act as RDQ Regulatory Intelligence Champion (RIC); partner across Quality, Clinical Development, Regulatory Affairs, Inspection Readiness.
- Monitor inspection trends/enforcement/health authority focus areas and support inspection readiness (e.g., FDA BIMO as needed).
Qualifications
Required:
- Bachelor’s degree in Life Sciences (or related).
- 8+ years in Quality, Regulatory Affairs/Intelligence, Quality Risk Management, Clinical Quality, or related GxP functions.
- Strong GxP regulations, inspection readiness, and quality management system knowledge.
- Governance/cross-functional experience; ability to translate complex regulatory information into actionable insights.
- Stakeholder facilitation/communication; experience influencing in matrixed organizations.
Preferred:
- Advanced degree.
- RI&S program/governance experience; quality risk management methodology/risk governance.
- Familiarity with ICH E6(R3), inspection trends, and emerging global expectations.
Pay/Compensation (as stated)
- Pay range: $160,600–$240,800; eligible for annual bonus and annual equity awards.
Associate Director 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.
Key Responsibilities
- Establish, implement, and continuously mature the RDQ RI&S process/operating model.
- Define and maintain RI&S intake, triage, escalation, impact assessment, and governance integration.
- Translate regulatory intelligence into actionable RDQ quality risk insights, recommendations, and readiness strategies.
- Integrate RI&S into RDQ quality risk management and governance forums; assess/escalate significant regulatory/inspection risks.
- Serve as Quality System Owner and RDQ representative for RI&S governance; represent RI&S in RDQ QLT, QMR, and risk review forums.
- Develop executive summaries/trend analyses and support RI&S integration into RDQ governance initiatives.
- Act as RDQ Regulatory Intelligence Champion (RIC); partner across Quality, Clinical Development, Regulatory Affairs, Inspection Readiness.
- Monitor inspection trends/enforcement/health authority focus areas and support inspection readiness (e.g., FDA BIMO as needed).
Qualifications
Required:
- Bachelor’s degree in Life Sciences (or related).
- 8+ years in Quality, Regulatory Affairs/Intelligence, Quality Risk Management, Clinical Quality, or related GxP functions.
- Strong GxP regulations, inspection readiness, and quality management system knowledge.
- Governance/cross-functional experience; ability to translate complex regulatory information into actionable insights.
- Stakeholder facilitation/communication; experience influencing in matrixed organizations.
Preferred:
- Advanced degree.
- RI&S program/governance experience; quality risk management methodology/risk governance.
- Familiarity with ICH E6(R3), inspection trends, and emerging global expectations.
Pay/Compensation (as stated)
- Pay range: $160,600–$240,800; eligible for annual bonus and annual equity awards.