Senior Director, GxP Training Quality & Compliance

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, and enterprise-wide learning transformation).
- Partner with Senior leaders across the Learning Organization to execute a rolling 3–5-year strategy to create value by adapting the GxP Training Quality & Compliance QMS to critical business needs.
- Drive change management for continuous improvement and embed it into daily work; develop and roll out a culture of learning performance with Product Development and Supply and cross-functional leadership.
- Serve as the enterprise authority on GxP Training Management; be the key point of contact for GxP Learning across internal and external Learning Ecosystems, ensuring optimization, compliance, and full integration into BMS Quality Management System (QMS).
- Position training quality as a strategic enabler of patient-centric outcomes and operational excellence.
- Ensure end-to-end flow of GxP Training processes related to requirements, managing identified interfaces between processes.
- Manage the GxP Training Quality and Compliance team supporting the GxP Learning Ecosystem.
- Build optimization competencies (e.g., Agile, Kaizen) within the team.
- Implement a risk-based, end-to-end learning approach across regulated functional areas throughout the product lifecycle.
- Identify opportunities to enhance processes and the BMS Quality strategy to improve efficiency, effectiveness, and user experience.
- Maintain and prioritize a portfolio of continuous improvement projects (bottoms-up simplification and top-down strategic levers).
- Identify, mitigate, and communicate critical risks.
- Develop/implement metrics, targets, and reporting mechanisms; collect and analyze data and monitor performance.
- Champion a Quality mindset/Culture of Quality.
- Support organization with GxP training related aspects of HA inspections.

Qualifications & Experience:
- Bachelor’s degree in Natural Science, Pharmacy, Life Sciences, Business Administration, or related field; advanced degree preferred.
- 15+ years biopharma/pharmaceutical industry experience in a regulated environment across Operations, Development, Quality, and/or related functions.
- 5+ years leadership experience driving business transformation at senior level.
- Thorough understanding of GxP regulatory requirements and Quality Management System elements (audits, inspections, investigations, CAPAs, change management, document management).
- Strategic decision-making balancing speed, quality, and risk.
- Demonstrated influencing skills across senior levels and disciplines; strong alignment-building.
- Program/project management experience managing cross-functional concurrent projects.
- Experience applying simplification/optimization approaches (Agile, Lean, Kaizen).
- Expertise facilitating issue resolution and aligning stakeholders.
- Track record developing/achieving metrics and scorecards.
- Exceptional executive written/oral communications and presentation skills; effective escalation.
- Enterprise mindset for matrixed work with diverse technical/cultural/geographic teams.