Bristol Myers Squibb is seeking an Associate Director, Quality Risk Specialist to develop the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (CtQ) data, processes, and vendors, demonstrating effective risk and issue management.
Requirements
- Develop the Quality Narrative at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes, and vendors demonstrating effective risk and issue management.
- Partner with Drug Development, to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes, and vendors and ensure adequate risk mitigation strategies have been implemented.
- Provide feedback on risks to study specific critical to quality factors and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.
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 (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees))
- 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
- Unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.
