Director, Development Quality Lead, Neuroscience

Bristol Myers Squibb

Devens, MA, US
Devens - ma - us: $200,840 - $243,368; madison - g...
50% onsite
Risk-based quality management strategies
Gcp, regulatory requirements
Quality by design principles
The Director, Development Quality - Neuroscience will be responsible for designing, developing, and implementing risk-based quality management strategies to ensure compliance with regulatory requirements, maintain trial data reliability, safeguard patient safety, and uphold study data quality

Job Summary

  • The Director, Development Quality - Neuroscience will be responsible for designing, developing, and implementing risk-based quality management strategies to ensure compliance with regulatory requirements, maintain trial data reliability, safeguard patient safety, and uphold study data quality.
  • Key responsibilities include overseeing the development of Quality Narratives, managing a team of Asset Quality Leads, partnering with Drug Development to drive adoption of Quality by Design principles, and ensuring risks to critical to quality factors are managed prospectively.
  • Bristol Myers Squibb offers a wide variety of competitive benefits and services, recognizing the importance of balance and flexibility, with opportunities for growth and development in a supportive culture.

Matching Summary

The Director, Development Quality - Neuroscience will be responsible for designing, developing, and implementing risk-based quality management strategies to ensure compliance with regulatory requirements, maintain trial data reliability, safeguard patient safety, and uphold study data quality.

Salary

Devens - MA - US: $200,840 - $243,368; Madison - Giralda - NJ - US: $187,700 - $227,445; Princeton - NJ - US: $187,700 - $227,445

Skills & Requirements

Must-have

  • Risk-based quality management strategies
  • GCP, regulatory requirements
  • Quality by Design principles
  • ICH (E8, E6, E9) compliance
  • Clinical trial process quality

Nice-to-have

  • Transforming patient lives
  • Growth and development opportunities
  • Balance and flexibility
  • Cross-functional collaboration
  • External engagement with industry

Key Requirements

  • Minimum 10+ years QA experience
  • B.S. and/or M.S. in relevant field
  • Neuroscience experience required
  • Applied knowledge of ICH/GCP
  • Risk-based quality management experience

Work Rights

Not specified

Tailored Resume

Cover Letter