Senior Director, GxP Training Quality & Compliance
Bristol Myers Squibb
July 02, 2026
Remote friendly (New Brunswick, NJ)
United States
Operations
Key Responsibilities
- Develop and execute the strategic roadmap for GxP Training Quality & Compliance to achieve long-term goals (speed to market, regulatory compliance, digital capability advancement, enterprise learning transformation).
- Partner with Learning Organization senior leaders on a rolling 3–5-year strategy to create value by adapting GxP Training QMS to business needs.
- Drive change management for continuous improvement and embed learning performance with Product Development, Supply, and cross-functional leadership.
- Serve as enterprise authority for GxP Training Management; ensure the Learning Ecosystem is optimized, compliant, and integrated into BMS QMS.
- Position training quality as a strategic enabler of patient-centric outcomes and operational excellence.
- Ensure end-to-end GxP Training process flow for requirements; manage interfaces between processes.
- Manage the GxP Training Quality and Compliance team.
- Build optimization competencies (e.g., Agile, Kaizen).
- Implement risk-based learning across end-to-end processes supporting regulated functional areas across the product lifecycle.
- Identify opportunities to enhance process and BMS Quality strategy; prioritize continuous improvement projects.
- Identify, mitigate, and communicate critical risks.
- Define and implement metrics/targets and reporting mechanisms; monitor performance.
- Champion a Quality mindset/Culture of Quality.
- Support GxP training aspects of HA inspections.
Qualifications & Experience
- Bachelor’s degree (Natural Science/Pharmacy/Life Sciences/Business Administration or related); advanced degree preferred.
- 15+ years biopharma/pharmaceutical industry experience in regulated environments (Ops/Development/Quality or related).
- 5+ years senior leadership experience driving transformation.
- Deep understanding of GxP regulatory requirements and Quality Management System elements (audits, inspections, investigations, CAPAs, change/document management).
- Strategic decision-making balancing speed, quality, and risk.
- Strong influencing, cross-functional program/project management, and issue-resolution facilitation.
- Demonstrated use of simplification/optimization approaches (Agile/Lean/Kaizen).
- Proven metrics/scorecards and exceptional executive communication.
Benefits (explicit)
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs (EAP, etc.); financial protection (401(k), disability, life insurance, and others).
- Develop and execute the strategic roadmap for GxP Training Quality & Compliance to achieve long-term goals (speed to market, regulatory compliance, digital capability advancement, enterprise learning transformation).
- Partner with Learning Organization senior leaders on a rolling 3–5-year strategy to create value by adapting GxP Training QMS to business needs.
- Drive change management for continuous improvement and embed learning performance with Product Development, Supply, and cross-functional leadership.
- Serve as enterprise authority for GxP Training Management; ensure the Learning Ecosystem is optimized, compliant, and integrated into BMS QMS.
- Position training quality as a strategic enabler of patient-centric outcomes and operational excellence.
- Ensure end-to-end GxP Training process flow for requirements; manage interfaces between processes.
- Manage the GxP Training Quality and Compliance team.
- Build optimization competencies (e.g., Agile, Kaizen).
- Implement risk-based learning across end-to-end processes supporting regulated functional areas across the product lifecycle.
- Identify opportunities to enhance process and BMS Quality strategy; prioritize continuous improvement projects.
- Identify, mitigate, and communicate critical risks.
- Define and implement metrics/targets and reporting mechanisms; monitor performance.
- Champion a Quality mindset/Culture of Quality.
- Support GxP training aspects of HA inspections.
Qualifications & Experience
- Bachelor’s degree (Natural Science/Pharmacy/Life Sciences/Business Administration or related); advanced degree preferred.
- 15+ years biopharma/pharmaceutical industry experience in regulated environments (Ops/Development/Quality or related).
- 5+ years senior leadership experience driving transformation.
- Deep understanding of GxP regulatory requirements and Quality Management System elements (audits, inspections, investigations, CAPAs, change/document management).
- Strategic decision-making balancing speed, quality, and risk.
- Strong influencing, cross-functional program/project management, and issue-resolution facilitation.
- Demonstrated use of simplification/optimization approaches (Agile/Lean/Kaizen).
- Proven metrics/scorecards and exceptional executive communication.
Benefits (explicit)
- Health coverage (medical, pharmacy, dental, vision); wellbeing programs (EAP, etc.); financial protection (401(k), disability, life insurance, and others).