This position will develop comprehensive internal and vendor quality oversight strategies for In Vitro Diagnostics (IVD), Companion Diagnostics (CDx), and Digital health assets within a regulated environment. The Director will serve as a key collaborator across external partners, internal R&D, Regulatory, Clinical, IT/Digital, and Quality organizations, ensuring fit-for-purpose, risk-based quality oversight aligned with a rapidly evolving global diagnostic and digital health regulatory landscape.
Requirements
- Serve as the primary Quality strategic partner to external diagnostic, CDx, SaMD, and digital health vendors, influencing quality expectations early in development lifecycles.
- Lead fit-for-purpose Quality frameworks for external partnerships, balancing innovation speed with regulatory compliance
- Drive partner engagement models that move beyond transactional audits toward continuous, risk-based oversight.
- Act as a change leader to modernize Quality practices traditionally designed for drugs/biologics to support diagnostics, software, and data-driven products.
- Own BMS global quality and audit strategies for diagnostic and Digital Health vendors, including CROS, Labs, software developers, and data providers
- Serve as a trusted inspection-facing leader, engaging directly with Health Authorities as needed.
- Utilizes Quality Risk Management (QRM) tools and innovative analytics/digital capabilities to achieve the optimal Quality Strategy in accordance with company objectives to proactively identify risk areas, streamline processes, and drive effectiveness and efficiency.
- Oversee vendor qualification audits and Third-Party Risk Management activities.
- Partner with business teams to address quality issues, including investigations, impact assessments, resolutions, and documentation.
- Lead/assist in the development and implementation of new Standard Operating Procedures (SOPs) as required.
- Coordinate inspection readiness activities and provide inspection support (e.g., inspection strategy room presence).
- Serve as the primary contact for PEARL assessments for IVD devices and SaMD (within GCP regulated area).
- Support GCP Deviation Root Cause investigations in partnership with Business stakeholders.
- Conduct business analysis to identify and implement continuous process improvements.
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
- US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
- Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
- Based on eligibility*, additional time off for employees may include 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.
