Director - Diagnostic & Digital Health Quality Strategy
Bristol Myers Squibb
10 hours ago
Remote friendly (Princeton, NJ)
United States
Operations
Position Summary
Develop comprehensive internal and vendor quality oversight strategies for In Vitro Diagnostics (IVD), Companion Diagnostics (CDx), and Digital health assets in a regulated environment. Report to Sr. Director of Laboratory Quality Assurance.
Responsibilities
- Serve as primary quality strategic partner to external diagnostic, CDx, SaMD, and digital health vendors; set quality expectations early.
- Lead fit-for-purpose quality frameworks and partner engagement models using continuous, risk-based oversight.
- Modernize quality practices for diagnostics, software, and data-driven products.
- Own global quality and audit strategies for diagnostic/Digital Health vendors (e.g., CROS, labs, software developers, data providers).
- Lead vendor qualification audits and Third-Party Risk Management.
- Support inspection readiness and inspection-facing activities; engage with Health Authorities as needed.
- Use QRM tools and analytics to identify risks, streamline processes, and drive effectiveness/efficiency.
- Partner on quality issues (investigations, impact assessments, resolutions, documentation); lead/assist SOP development.
- Manage PEARL assessments for IVD devices and SaMD (within GCP regulated area) and support GCP deviation root cause investigations.
Qualifications & Skills
- BS in Life Sciences/Engineering (advanced degree preferred).
- Experience in IVD/CDx/SaMD quality management, vendor oversight, and audit strategy.
- Expertise in diagnostic/digital health audits (design controls, software validation, data integrity, lifecycle management).
- Knowledge of GCP, ISO, GLP, GMP; risk management frameworks; lead investigations/root cause analysis.
- Strong communication, negotiation, presentation, and cross-functional partnering.
- Additional: PEARL assessment/strategy room knowledge; experience developing/maintaining SOPs; change management.
Compensation/Benefits (as stated)
- $188,250–$228,114 (Princeton, NJ).
- Health coverage, 401(k), disability/life/other protection, and paid time off (details by eligibility).
Develop comprehensive internal and vendor quality oversight strategies for In Vitro Diagnostics (IVD), Companion Diagnostics (CDx), and Digital health assets in a regulated environment. Report to Sr. Director of Laboratory Quality Assurance.
Responsibilities
- Serve as primary quality strategic partner to external diagnostic, CDx, SaMD, and digital health vendors; set quality expectations early.
- Lead fit-for-purpose quality frameworks and partner engagement models using continuous, risk-based oversight.
- Modernize quality practices for diagnostics, software, and data-driven products.
- Own global quality and audit strategies for diagnostic/Digital Health vendors (e.g., CROS, labs, software developers, data providers).
- Lead vendor qualification audits and Third-Party Risk Management.
- Support inspection readiness and inspection-facing activities; engage with Health Authorities as needed.
- Use QRM tools and analytics to identify risks, streamline processes, and drive effectiveness/efficiency.
- Partner on quality issues (investigations, impact assessments, resolutions, documentation); lead/assist SOP development.
- Manage PEARL assessments for IVD devices and SaMD (within GCP regulated area) and support GCP deviation root cause investigations.
Qualifications & Skills
- BS in Life Sciences/Engineering (advanced degree preferred).
- Experience in IVD/CDx/SaMD quality management, vendor oversight, and audit strategy.
- Expertise in diagnostic/digital health audits (design controls, software validation, data integrity, lifecycle management).
- Knowledge of GCP, ISO, GLP, GMP; risk management frameworks; lead investigations/root cause analysis.
- Strong communication, negotiation, presentation, and cross-functional partnering.
- Additional: PEARL assessment/strategy room knowledge; experience developing/maintaining SOPs; change management.
Compensation/Benefits (as stated)
- $188,250–$228,114 (Princeton, NJ).
- Health coverage, 401(k), disability/life/other protection, and paid time off (details by eligibility).