Associate Director, Quality Risk Specialist

Bristol Myers Squibb

Devens, MA, US
Base: $163,850 - $212,438 depending on location; b...
Hybrid (50% onsite)
Risk based quality management principles
Ich gcp regulatory compliance knowledge
Critical to quality data management
Bristol Myers Squibb is seeking an Associate Director, Quality Risk Specialist, to oversee risk-based quality management in clinical trials across various therapeutic areas. This role requires extensive experience in quality assurance, risk management, and a deep understanding of regulatory compliance in clinical research

Job Summary

  • The role focuses on developing end-to-end risk-based quality management narratives for critical data and processes across multiple therapeutic areas.
  • Candidates will partner with drug development teams to embed Quality by Design principles during the upstream protocol authoring process.
  • Bristol Myers Squibb offers competitive benefits including flexible time off, health coverage, and a supportive work-life balance environment.

Matching Summary

Match Score: 85

Bristol Myers Squibb is seeking an Associate Director, Quality Risk Specialist, to oversee risk-based quality management in clinical trials across various therapeutic areas. This role requires extensive experience in quality assurance, risk management, and a deep understanding of regulatory compliance in clinical research.

Salary

Base: $163,850 - $212,438 depending on location; Bonus/Equity: Additional incentive cash and stock opportunities available; Benefits: Medical, dental, vision, 401(k), paid time off, and wellbeing support programs

Skills & Requirements

Must-have

  • Risk Based Quality Management principles
  • ICH GCP regulatory compliance knowledge
  • Critical to Quality data management
  • Quality Narrative development experience
  • Clinical trial lifecycle consultation

Nice-to-have

  • Therapeutic area expertise in oncology
  • Cross-functional team leadership skills
  • Regulatory inspection preparation experience
  • Proactive quality culture mentoring

Key Requirements

  • Minimum 8+ years QA or quality management experience
  • Bachelor's or Master's degree in Chemistry, Biology, Health, or Quality field
  • Demonstrated applied knowledge of ICH/GCP and regulatory guidelines

Work Rights

Not specified

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