The Associate Director, Quality Risk management will develop the Quality Narrative at the study and/or ASSET and Therapeutic Area levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management.
Requirements
- B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
- Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance
- Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance
- Extensive experience in regulatory inspection preparation, management, and related follow-up
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
- Paid Time Off
- Flexible time off (unlimited, with manager approval), 11 paid national holidays
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Global Shutdown between Christmas and New Years Day
