Senior Director, Risk Governance and Operations, R&D Quality

Bristol-Myers Squibb - Summit, NJ

Full-time - Senior

Summit, NJ

Chemical Manufacturing

About the position

The Senior Director, Risk Governance and Operations, R&D Quality at Bristol Myers Squibb is a pivotal role that involves leading the integration of risk management and quality assurance within the research and development (R&D) framework. This position requires a strategic thinker who can collaborate closely with R&D Quality GxP Heads, Global Quality, and Enterprise Risk functions to effectively manage and communicate risks and their mitigations to management boards. The Senior Director will play a crucial role in advancing the overall Global Quality vision and strategy, ensuring that quality processes are embedded throughout the drug development lifecycle. In this role, the Senior Director will define, own, and execute R&D Quality processes that contribute to the Drug Development's end-to-end Risk Based Management (RBM) framework across the clinical trial portfolio. This includes working with clinical trial teams to identify critical quality data, processes, and vendors, as well as developing risk mitigation strategies that are integrated into operational plans. The Senior Director will also provide quality and compliance consultation throughout the study lifecycle, ensuring that significant quality issues and protocol deviations are effectively managed. The position requires a strong focus on quality governance and risk management, where the Senior Director will lead the development and sustainment of an effective quality governance model across nonclinical, clinical, and pharmacovigilance areas. This includes driving the management of R&D Quality Councils and ensuring that quality risks are assessed and reported to Global Quality Councils and Enterprise Risk Committees. The Senior Director will also oversee the management of Corrective and Preventive Actions (CAPAs) arising from deviations, audits, and inspections, ensuring that root cause analyses are conducted and that the CAPA process is continuously improved. Additionally, the Senior Director will coordinate R&D Quality Leadership Team meetings, support the development of the overall R&D Quality strategy, and manage performance metrics to ensure alignment with Global Quality strategies. This role is essential for fostering a culture of quality and compliance within the organization, ultimately contributing to the mission of transforming patients' lives through science.

Responsibilities

• Define, own, and execute R&D Quality processes contributing to Drug Development's end-to-end Risk Based Management (RBM) framework across the clinical trial portfolio.
• Collaborate with clinical trial teams to provide R&D Quality expertise and critical thinking as part of the upstream protocol authoring process.
• Identify critical to quality (CtQ) data, processes, and vendors, and develop risk mitigation strategies integrated into operational plans.
• Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt operational and quality plans accordingly.
• Lead and author the overall Quality Narrative to document the end-to-end risk-based quality management for CtQ data, processes, and vendors.
• Ensure effective management of significant quality issues/non-compliance and important protocol deviations for CtQ data, processes, and vendors.
• Drive continuous improvement by establishing feedback loops to incorporate lessons learned into future trials.
• Provide R&D Quality Leadership in developing and sustaining an effective quality and compliance governance model across nonclinical, clinical, and pharmacovigilance.
• Lead the development and delivery of meaningful data and information for R&D Quality council oversight, ensuring a risk-based and data-driven approach.
• Manage CAPAs from deviations, audits, inspections, and quality events, ensuring clear tracking and metrics to drive on-time performance.

Requirements

• Minimum of BA/BS degree or in a life science discipline; advanced education preferred.
• Minimum 15 years of Quality experience or relevant BioPharma experience, with demonstrated experience in R&D and R&D Quality roles.
• Experience in quality risk management and the application of Quality by Design in clinical trials.
• Knowledge and experience in GxP global regulations necessary for appropriate strategy setting, decision making, and quality oversight.
• Previous experience dealing with regulatory agencies in policy development, inspections, investigations, and audits.
• Demonstrated ability to work effectively in a matrix environment and drive results through influence as well as direct management.
• Ability to develop/translate long-range strategic plans into short-range operational processes/systems/goals.
• Experience in managing teams, providing coaching, development, and mentoring to employees.
• Broad understanding of digital and data, including AI, automation, advanced analytics, etc.
• Proven problem-solving skills to prevent and overcome complex process and quality-related issues.

Nice-to-haves

• Experience in a leadership role within a global organization.
• Familiarity with advanced analytics and data-driven decision-making processes.
• Experience in training and educating teams on quality management practices.

Benefits

• Competitive salary
• Comprehensive health insurance
• 401k retirement plan
• Flexible work arrangements
• Paid time off and holidays
• Professional development opportunities
• Employee wellness programs