Bristol Myers Squibb is seeking a Director, Development Quality Lead for their Neuroscience portfolio, responsible for implementing risk-based quality management strategies in clinical trials. The ideal candidate should have extensive experience in quality assurance, particularly in neuroscience, and strong leadership skills to manage teams and drive quality practices
Job Summary
Responsible for designing, developing, and implementing risk-based quality management strategies to ensure compliance, reliability of trial results, patient safety, and data quality.
Oversee the development of Quality Narratives and manage a team of Asset Quality Leads, providing guidance and development opportunities.
Partner with Drug Development to drive adoption of Quality by Design principles and ensure risks to critical quality factors are managed prospectively.
Matching Summary
Match Score: 85
Bristol Myers Squibb is seeking a Director, Development Quality Lead for their Neuroscience portfolio, responsible for implementing risk-based quality management strategies in clinical trials. The ideal candidate should have extensive experience in quality assurance, particularly in neuroscience, and strong leadership skills to manage teams and drive quality practices.
Salary
Base: $187,700 - $243,368; Bonus/Equity: Additional incentive cash and stock opportunities; Benefits: Health Coverage, Wellbeing Support, Financial Well-being and Protection, Work-life benefits
Skills & Requirements
Must-have
GCP compliance
Risk-based quality management
Clinical trial data integrity
Regulatory compliance (ICH E8, E6, E9)
Quality by Design principles
Nice-to-have
Leadership and team development
External engagement with regulatory agencies
Mentoring and coaching
Cross-functional collaboration
Key Requirements
Neuroscience experience required
B.S. and/or M.S. in Chemistry, Biology, or Health/Quality related field
Minimum 10+ years QA experience or relevant experience
Demonstrated applied knowledge of ICH/GCP
Very experienced in Risk Based Quality Management principles