Director – Diagnostic & Digital Health Quality Strategy

Bristol Myers Squibb • Princeton, NJ

3d • Hybrid

About The Position

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us. Position Summary: 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. This role is accountable for the development, implementation, and continuous improvement of QMS processes and oversight, including global audit strategy, vendor quality oversight, inspection readiness, and regulatory intelligence for IVD, CDx and Digital health programs. This position will report to the Sr. Director of Laboratory Quality Assurance.

Requirements

• Bachelor’s degree in Life Sciences, Engineering, or related field; advanced degree preferred.
• Experience in quality management, vendor oversight, and audit strategy in the IVD, CDx, or SaMD sector.
• Demonstrate deep expertise in diagnostic and digital health-specific audit execution, including design controls, software validation, data integrity, and lifecycle management.
• Comprehensive knowledge of GCP, ISO, GLP, GMP relevant regulatory requirements, and risk management frameworks.
• Demonstrated experience leading investigations and root cause analysis.
• Strong written and verbal communication skills; ability to partner across functions.
• Analytical mindset with a focus on process improvement and compliance.

Nice To Haves

• Knowledge of PEARL assessments and strategy room operations during regulatory inspections.
• Experience developing and maintaining SOPs.
• Capacity for business partnering and change management in a dynamic environment.

Responsibilities

• 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.
• Effective verbal and written communication and interpersonal relationship skills.
• Skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management.
• Good presentation skills, deliver focused message to audience of peers, stakeholders and Regulatory Agency Inspectors
• Demonstrates flexibility, open-mindedness and adaptability to a rapidly changing environment.

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.
• Work-life benefits include: 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. All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.
• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the program.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees