Director, PV Global Process Lead (GPL)
Bristol Myers Squibb
August 24, 2026
Remote friendly (Princeton, NJ)
United States
Operations
Responsibilities:
- Lead design, optimization, and oversight of the Safety Aggregate Reporting (SAR) process; ensure effectiveness, inspection readiness, and regulatory alignment.
- Partner with Global Process Owners to define and deliver process strategies/roadmaps with cross-functional visibility.
- Serve as principal subject matter expert for SAR and related interfaces; engage Local Markets and governance bodies for consistent oversight.
- Lead Communities of Practice; drive knowledge sharing and adoption of best practices.
- Drive metric-based demand/capacity planning using benchmarking and KPIs.
- Lead Policy Evaluation and Regulatory Landscape (PEARL) assessments; oversee implementation.
- Define, monitor, and report process health metrics (cycle times, efficiency, productivity).
- Map processes in process-mapping tools (e.g., Adonis) and maintain procedural documentation and PV System Master File sections; support training impact assessment.
- Partner with BCE and Strategy & Operations on process improvements, tools, and technology.
- Represent the organization externally (working groups, benchmarking forums, conferences).
Qualifications/Requirements:
- Bachelor’s degree or equivalent experience; advanced degree preferred.
- Extensive pharmacovigilance experience with deep SAR expertise and knowledge of other core PV processes.
- Proven end-to-end process ownership (design, mapping, optimization, governance).
- Skilled in authoring/maintaining procedural documents.
- Experience with global regulatory requirements and regulatory inspection readiness/follow-up.
- Experience leading cross-functional governance and Communities of Practice; external engagement.
- Strong KPI measurement, benchmarking, and process monitoring.
Key Competencies:
- Strategic regulatory/technical process leadership; strong analytical and communication skills; change leadership; global mindset.
Travel: Limited (up to 5%).
Benefits (as stated): medical/dental/vision; wellbeing support; 401(k), disability/life/accident insurance; business travel protection; paid time off.
If you don’t perfectly match, you’re encouraged to apply anyway.
- Lead design, optimization, and oversight of the Safety Aggregate Reporting (SAR) process; ensure effectiveness, inspection readiness, and regulatory alignment.
- Partner with Global Process Owners to define and deliver process strategies/roadmaps with cross-functional visibility.
- Serve as principal subject matter expert for SAR and related interfaces; engage Local Markets and governance bodies for consistent oversight.
- Lead Communities of Practice; drive knowledge sharing and adoption of best practices.
- Drive metric-based demand/capacity planning using benchmarking and KPIs.
- Lead Policy Evaluation and Regulatory Landscape (PEARL) assessments; oversee implementation.
- Define, monitor, and report process health metrics (cycle times, efficiency, productivity).
- Map processes in process-mapping tools (e.g., Adonis) and maintain procedural documentation and PV System Master File sections; support training impact assessment.
- Partner with BCE and Strategy & Operations on process improvements, tools, and technology.
- Represent the organization externally (working groups, benchmarking forums, conferences).
Qualifications/Requirements:
- Bachelor’s degree or equivalent experience; advanced degree preferred.
- Extensive pharmacovigilance experience with deep SAR expertise and knowledge of other core PV processes.
- Proven end-to-end process ownership (design, mapping, optimization, governance).
- Skilled in authoring/maintaining procedural documents.
- Experience with global regulatory requirements and regulatory inspection readiness/follow-up.
- Experience leading cross-functional governance and Communities of Practice; external engagement.
- Strong KPI measurement, benchmarking, and process monitoring.
Key Competencies:
- Strategic regulatory/technical process leadership; strong analytical and communication skills; change leadership; global mindset.
Travel: Limited (up to 5%).
Benefits (as stated): medical/dental/vision; wellbeing support; 401(k), disability/life/accident insurance; business travel protection; paid time off.
If you don’t perfectly match, you’re encouraged to apply anyway.