Senior Director, QMS Lifecycle Management & Operational Controls

Working with Us
Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more: careers.bms.com/working-with-us.

Position Summary

Reporting to the Executive Director, Compliance Enabling QMS, this role develops and executes the strategic roadmap for the Lifecycle Management and Operational Controls pillars to achieve long term strategic goals (e.g. speed to market, expanding BMS’ pipeline portfolio, advancing digital capabilities, etc.) through the Process framework elements of BMS’ Quality Management System (QMS). This includes ensuring requirements are optimized and implemented in a way that seamlessly integrate into all functions and work in tandem with the Governance Controls Processes and Systems.

Key Responsibilities:

• Influence and align QMS focus areas over the strategic time horizon with senior leaders

• Accountable for the end-to-end flow of QMS processes related to requirements, ensuring interfaces between processes are identified, efficient and well managed.

• Partner with Senior leaders across the Research and Development and Commercial Operations organizations to develop and execute a rolling 3-5 year strategy that identifies tangible areas of value creation by adapting the QMS to meet critical business needs.

• Ensure the core competencies of optimization driven by BMS including Compass are built within the team (e.g. Agile, Kaizen, etc.).

• 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.

• Partner with local sites and markets to ensure they maintain document management capabilities, pull through global QMS requirements into their local documentation, are in a continuous state of inspection readiness, and actively participate in QMS changes that will directly impact their operations.

• 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.

Qualifications & Experience:

• Bachelor’s degree in Natural Science, Pharmacy, or related field required.

• A minimum of 15 years of experience in the biopharma/pharmaceutical industry, with at least ten (10) years of experience managing people and teams

• A minimum of 5 years leadership experience in driving business transformations

• Thorough understanding of GxP regulatory requirements

• Strong program/project management experience with proven record of managing cross-functional programs and ability to oversee multiple projects.

• Strategic thinking capability with ability to make and act on decisions while balancing speed, quality and risk to deliver value added business results that meet quality requirements.

• Demonstrated influencing skills with senior levels over multiple disciplines.

• Excellent teamwork, interpersonal, and communication / listening skills, with the ability to collaborate with employees/management at all levels.

• Demonstrated ability to apply simplification and optimization approaches.

• Expertise in facilitating issue resolution, including ensuring alignment across multiple stakeholders on path forward.

• Enterprise mindset to work in a matrixed organization with a range of technically, culturally, and geographically

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