Senior Director, GxP Training Quality & Compliance

Bristol Myers Squibb • Devens, MA

3d • $210,190 - $272,528 • Hybrid

About The Position

This role develops and executes the strategic roadmap for GxP Training Quality & Compliance to achieve long term strategic goals — including speed to market, regulatory compliance, digital capability advancement, and enterprise-wide learning transformation. Partner with Senior leaders across the Learning Organization to develop and execute a rolling 3–5-year strategy that identifies tangible areas of value creation by adapting the GxP Training Quality & Compliance QMS to meet critical business needs. Drive change management to promote a culture of continuous improvement and embedding it into our daily work, partnering with Product Development and Supply and cross-functional leadership in developing and rolling out a culture of learning performance. This role serves as the enterprise authority on GxP Training Management, serving as the key point of contact for GxP Learning in both internal and external Learning Ecosystem, ensuring the Learning Ecosystem is optimized, compliant, and fully integrated into the BMS Quality Management System (QMS). The Senior Director partners with senior leaders across Research & Development, Commercial Operations, and Product Development and Supply to position training quality as a strategic enabler of patient-centric outcomes and operational excellence. Accountable for the end-to-end flow of GxP Training processes related to requirements, ensuring interfaces between processes are identified, efficient and well managed. Manage GxP Training Quality and Compliance team in support of delivering GxP Learning Ecosystem Ensure the core competencies of optimization driven by BMS including Compass are built within the team (e.g. Agile, Kaizen, etc.). Implement a risk-based learning approach for end to end (E2E) processes supporting regulated functional areas across the product lifecycle. Provide input and identify opportunities to enhance process and the BMS Quality strategy to support prioritization and enhance efficiency, effectiveness, and user experience Maintain and prioritize portfolio of both bottoms-up (i.e., simplification opportunities at the process level) and top-down (i.e., strategic levers) continuous improvement projects. Identify, mitigate and communicate critical risks. Develop and implement defined metrics, associated targets, and reporting mechanisms including data collection and analysis, and monitor performance to ensure expected outcomes are met. Champion a Quality mindset / Culture of Quality. Support organization with GxP training related aspects of HA inspections

Requirements

• Bachelor's degree in Natural Science, Pharmacy, Life Sciences, Business Administration, or a related field; advanced degree preferred.
• A minimum of 15 years of experience in the biopharma/pharmaceutical industry in a regulated environment, spanning Operations, Development, Quality, and/or related functions.
• A minimum of 5 years of leadership experience driving business transformation at a senior level.
• Thorough understanding of GxP regulatory requirements and broad familiarity with Quality Management System elements (audits, inspections, investigations, CAPAs, change management, document management).
• Strong strategic thinking capability with the ability to make and act on decisions while balancing speed, quality, and risk to deliver value-added business results.
• Demonstrated influencing skills across senior levels and multiple disciplines; exceptional ability to build alignment with senior business partners.
• Strong program/project management experience with a proven record of managing cross-functional programs and overseeing multiple concurrent projects.
• Demonstrated ability to apply simplification and optimization approaches (e.g., Agile, Lean, Kaizen).
• Expertise in facilitating issue resolution, including ensuring alignment across multiple stakeholders on path forward.
• A history of developing and achieving key metrics and scorecards.
• Exceptional executive written and oral communications and outstanding presentation skills, with proven ability to escalate critical issues effectively.
• Enterprise mindset to work in a matrixed organization with colleagues who are technically, culturally, and geographically diverse.

Nice To Haves

• Advanced degree preferred.

Responsibilities

• Develops and executes the strategic roadmap for GxP Training Quality & Compliance.
• Partners with Senior leaders across the Learning Organization to develop and execute a rolling 3–5-year strategy.
• Drives change management to promote a culture of continuous improvement.
• Serves as the enterprise authority on GxP Training Management.
• Ensures the Learning Ecosystem is optimized, compliant, and fully integrated into the BMS Quality Management System (QMS).
• Partners with senior leaders across Research & Development, Commercial Operations, and Product Development and Supply.
• Accountable for the end-to-end flow of GxP Training processes related to requirements.
• Manages GxP Training Quality and Compliance team.
• Implements a risk-based learning approach for end to end (E2E) processes.
• Provides input and identifies opportunities to enhance process and the BMS Quality strategy.
• Maintains and prioritizes portfolio of continuous improvement projects.
• Identifies, mitigates and communicates critical risks.
• Develops and implements defined metrics, associated targets, and reporting mechanisms.
• Champions a Quality mindset / Culture of Quality.
• Supports organization with GxP training related aspects of HA inspections.

Benefits

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing 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.
• Work-life benefits include: Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
• Based on eligibility, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior