This role is responsible for designing, developing, and implementing risk-based quality management strategies to ensure compliance, reliability, patient safety, and data quality throughout the clinical trial process
Job Summary
This role is responsible for designing, developing, and implementing risk-based quality management strategies to ensure compliance, reliability, patient safety, and data quality throughout the clinical trial process.
Key responsibilities include overseeing quality narratives, managing a team of Asset Quality Leads, partnering with Drug Development to adopt Quality by Design, and ensuring risks to critical quality factors are managed prospectively.
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
This role is responsible for designing, developing, and implementing risk-based quality management strategies to ensure compliance, reliability, patient safety, and data quality throughout the clinical trial process.
Salary
Base: $200,840 - $243,368 (Devens, MA); $187,700 - $227,445 (Madison, NJ; Princeton, NJ); 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
GCP, regulatory guidelines, clinical research
Neuroscience portfolio quality strategies
Quality by Design principles adoption
ICH E8, E6, E9 compliance
Nice-to-have
Drive quality into the business
External engagement with regulators
Mentoring and coaching capabilities
Adaptability to changing business conditions
Key Requirements
Minimum 10+ years QA experience
B.S. and/or M.S. in Chemistry, Biology, or Health/Quality related field
Neuroscience experience required
Experience in regulatory inspection preparation and management