Associate Director, Quality Risk Specialist

Bristol Myers Squibb

Devens, MA, US
Base: $163,850 - $212,438; bonus/equity: + incenti...
50% onsite
Risk-based quality management principles
Ich/gcp regulatory guidelines
Clinical research processes
Develop the Quality Narrative to document end-to-end risk-based quality management for critical to quality data, processes, and vendors, demonstrating effective risk and issue management

Job Summary

  • Develop the Quality Narrative to document end-to-end risk-based quality management for critical to quality data, processes, and vendors, demonstrating effective risk and issue management.
  • Provide quality and compliance consultation to clinical trials teams throughout the study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise.
  • Bristol Myers Squibb offers a wide variety of competitive benefits, services and programs that provide employees with the resources to pursue their goals, both at work and in their personal lives.

Matching Summary

Develop the Quality Narrative to document end-to-end risk-based quality management for critical to quality data, processes, and vendors, demonstrating effective risk and issue management.

Salary

Base: $163,850 - $212,438; Bonus/Equity: Additional incentive cash and stock opportunities may be available; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits

Skills & Requirements

Must-have

  • Risk-Based Quality Management principles
  • ICH/GCP regulatory guidelines
  • Clinical research processes
  • Quality Assurance principles
  • Applied risk-management knowledge

Nice-to-have

  • Proactive quality support
  • Mentoring and coaching
  • Cross-functional team leadership
  • Continuous improvement culture
  • External stakeholder engagement

Key Requirements

  • B.S. and/or M.S. degree or equivalent experience
  • Minimum 8+ years QA experience
  • Experience in quality management, biomedical science, clinical development, or regulatory compliance
  • Experience in regulatory inspection preparation and management

Work Rights

Not specified

Tailored Resume

Cover Letter