R&d Quality Senior Manager, Quality Risk Management

Vrtx

Base: $133,800 - $200,600; bonus/equity: eligible ...
Hybrid: work remotely up to two days per week or work five days per week on-site with ad hoc flexibility.
R&d quality value chain
Holistic, proactive, end-to-end approach
Risk-based thinking
Vertex is seeking a Senior Manager for R&D Quality Governance & Risk Management to lead quality risk management in clinical development. The role emphasizes proactive risk identification and mitigation in compliance with GxP standards, requiring strong collaboration across R&D functions

Job Summary

  • The Sr. Manager, R&D Quality (RDQ) Governance & Risk Management plays a critical role in Vertex’s R&D Quality value chain by driving a holistic, proactive, and end-to-end approach to quality risk management (QRM) across clinical development.
  • This role ensures that risk-based thinking is embedded into R&D processes, decisions, and governance, partnering closely with R&D functional leaders to influence decision-making and support strategic mitigation planning.
  • The Sr. Manager will strengthen the infrastructure of R&D quality risk management, support R&D governance implementation and management, and enhance risk transparency through data, analytics, and standardized tools.

Matching Summary

Match Score: 85

Vertex is seeking a Senior Manager for R&D Quality Governance & Risk Management to lead quality risk management in clinical development. The role emphasizes proactive risk identification and mitigation in compliance with GxP standards, requiring strong collaboration across R&D functions.

Salary

Base: $133,800 - $200,600; Bonus/Equity: Eligible for annual bonus and annual equity awards; Benefits: Inclusive market-leading benefits

Skills & Requirements

Must-have

  • R&D Quality value chain
  • holistic, proactive, end-to-end approach
  • risk-based thinking
  • GCP, GVP, GLP domains
  • patient privacy & safety
  • regulatory compliance
  • clinical trial data integrity
  • inspection readiness

Nice-to-have

  • strategic considerations
  • hands-on execution
  • data-driven decision making
  • continuous improvement

Key Requirements

  • 5+ yrs experience in Pharmaceutical / Biotech / Medical Device Quality Assurance / Compliance
  • Experience with GxP risk management
  • Ability to analyze complex scenarios
  • Experience with risk assessment approaches
  • Proficiency with project management tools

Work Rights

Not specified

Tailored Resume

Cover Letter