Director, Quality Excellence and Governance

Bristol Myers Squibb • Devens, MA

3d • Hybrid

About The Position

The Director of Quality Excellence and Governance is responsible for driving a culture of quality excellence across R&D Quality (RDQ) operations and ensuring robust governance of quality systems, processes, and performance. This role will lead strategic initiatives to harmonize quality standards, embed proactive and predictive quality principles, and oversee governance frameworks that enable compliance, operational efficiency, and continuous improvement. The position serves as a key partner to senior leadership, ensuring transparency, accountability, and alignment with global regulatory expectations and enterprise objectives. The role supports data-driven decision-making, fosters cross-functional collaboration, and promotes ongoing innovation. Additionally, this position advocates for a culture focused on quality, operational excellence, and continuous improvement.

Requirements

• B.S. and/or M.S. in engineering, scientific or related field.
• Subject matter expert in Drug Development related regulations, standards, best practices.
• Minimum 10+ years in biopharmaceutical/life-sciences industries is preferred.
• Proven experience in Quality Risk Management, Operating Excellence, Project Management, and leading operations or continuous improvement teams.
• Demonstrated leadership skills, including the ability to remove roadblocks, establish priorities, and maintain compliance sustainability.
• Leadership experience and effective communication with stakeholders at all levels, along with a keen attention to detail.
• Exceptional strategic thinking abilities, adept at managing complex systems, navigating organizational politics, fostering innovation, and skilled in negotiation and management.
• Possesses a strategic perspective, leading with vision and values, exhibiting global acumen, and displaying a strong leadership disposition.
• Strong customer focus, interpersonal and organizational skills, with a collaborative and teamwork-oriented mindset.
• Proven ability to manage multiple tasks in a fast-paced environment.
• Adept at working effectively across functional groups and teams to achieve objectives.
• Demonstrated competencies in influencing, negotiating, relationship management, and a continuous improvement mindset.
• Budget management experience, possesses an enterprise mindset, making decisions and sharing resources for the greater benefit.
• Change agility, with the ability to navigate ambiguity, take calculated risks, and lead others through change.
• Strong organizational and problem-solving abilities, with a sense of urgency and the capacity to manage priorities and timelines effectively.

Nice To Haves

• PMP and/or Six Sigma / Lean certifications are preferred.

Responsibilities

• Provide strategic leadership to oversee the implementation and continuous improvement of the R&D Quality Risk Management framework, ensuring effective roll-up and reporting of risks and insights to relevant governance forums.
• Define and lead the R&D Quality Excellence and Governance strategy aligned with regulatory expectations, industry standards, and enterprise objectives.
• Ensure alignment of Quality Strategy with ICH E6(R3), ICH E8(R1), Q9, BMS Quality Plan and applicable global regulations.
• Lead the development and oversight of R&D Quality performance metrics to ensure effective consolidation and communication to Global Quality, Drug Development, Global Product Supply and Research, as applicable, in partnership with teams across RDQ.
• Partner with Corporate Quality (CQ) and Global Quality (GQ) and maintain a RDQ quality governance framework, including councils, committees, and escalation pathways.
• Partner with GQ/CQ to oversee governance of quality policies, standards, and procedures, ensuring alignment with ICH, FDA, EMA, and other global regulations.
• Monitor and report quality performance metrics, RDQ compliance dashboards and risk indicators to senior leadership and enterprise governance bodies.
• Serve as a primary liaison for GQ and Drug Development to provide executive oversight of the R&D Quality Management System (QMS), ensuring scalability, consistency, and compliance with the BMS Quality Plan.
• Partner with the GPO and BPO network to provide Quality input into Business Process Management and ensuring the QMS is fit for purpose for R&D.
• Partner with RDQ LT and relevant pillars within RDQ to establish a mechanism for risk-based oversight models for clinical programs, operations, service providers, and strategic partners.
• Champion compliance with key ICH guidelines (e.g. E6, E8, E9, Q9) and other relevant regulatory requirements.
• Influence senior stakeholders to embed quality ownership at all levels.
• Drives Quality Risk Management solutions for RDQ in collaboration with RDQLT, GQ and Drug Development.
• Facilitate root cause investigations, CAPA management, and review/approval of CAPA plans, as needed.
• Drive continuous improvement initiatives to enhance quality processes, systems, and inspection readiness.
• Develop and deliver training programs to enhance quality awareness and competencies across the organization, as needed.
• Ensure rapid communication and escalation of quality issues, including potential misconduct or significant deviations, to the business and Health Authorities as needed
• Ensure effective identification, mitigation, and prevention of risks impacting subject safety, data integrity, and compliance
• Lead and Support the GCP serious non-compliance management process, including management of Serious Breaches, leading investigations and development of CAPA plan.
• Collaborate with Global Quality, Strategy and Business Excellence, to set goals for RDQ that are specific, measurable, achievable, relevant, and aligned to the enterprise strategies, and time bounded.
• Partner with RDQLT and conduct comprehensive data analysis and interrogation of data to derive meaningful, actionable insights that support data-driven decision-making and proactive signal detection for R&D Quality Council.
• Provides clear, actionable quality insights to senior leadership and governance committees.
• Create a comprehensive plan that outlines the scope, timeline, resources, and key milestones for strategic initiatives taking into consideration potential risk and mitigations.
• Translate complex quality data into strategic insights, highlighting systemic risks, trends, and opportunities
• Provide routine and ad hoc quality consultation to study teams and other Drug Development functions, as needed.
• Provide coordination and support for R&D Quality Leadership Team meetings, ensuring rigor in cadence, agenda, actions and follow-up, if needed.
• Champion a Quality Mindset and oversee strategic planning processes such as setting clear initiatives, developing strategic plans, engaging stakeholders, allocation of resources, assigning clear responsibilities, communication, risk management, continuous improvement, etc.
• Provide leadership for program governance, operations, and benefits realization such as but not limited to; successful attainment and utilization of the intended advantages, outcomes, or gains that were identified as part of the project objectives.
• Encourage a culture of continuous improvement and innovation within the pillar and each strategic initiative to adapt to evolving industry trends and challenges.
• Lead communication efforts and serve as a role model for company values.
• Maintaining adoption, connectivity, and alignment with GPS, GQ, DD and Early Research & cross-functional partnership with key stakeholders such as Finance, HR, External Engagement, BIT, Communication, and Change Management.
• Establish strong partnerships with business stakeholders.
• Track the external landscape and stay informed about industry practices and new regulations and developments in the risk management space.
• Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline.
• Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department.
• Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.

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.
• All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 5,001-10,000 employees