Director - Diagnostic & Digital Health Quality Strategy

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.

Key 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.
• Utilize 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.
• Demonstrate effective verbal and written communication and interpersonal relationship skills.
• Act as a skilled negotiator, able to influence and obtain cooperation from colleagues, business partners and other stakeholders, including senior management.
• Deliver clear presentations to peers, stakeholders and Regulatory Agency Inspectors.
• Demonstrate flexibility, open‑mindedness and adaptability to a rapidly changing environment.

Qualifications

• 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.

Additional Skills

• 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.

Compensation Overview

Princeton - NJ - US: $188,250 - $228,114 (full‑time employee).

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Well‑being 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) and 11 paid national holidays (specific exclusions apply); additional time off includes unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, and various leaves of absence. Global Shutdown available to all eligible employees between Christmas and New Year’s Day.

Supporting People With Disabilities

BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer.

Candidate Rights

BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in the applicant’s area.

R : Director – Diagnostic & Digital Health Quality Strategy

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