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

Bristol-Myers Squibb - Princeton, NJ

Full-time - Senior

Princeton, 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 Risk Based Quality Management initiatives within the R&D Quality department. This position requires close collaboration with the R&D Quality GxP Heads, Global Quality, R&D, and Enterprise Risk functions to effectively manage and communicate risks and their mitigations to the respective management boards. The Senior Director will play a crucial role in advancing the overall Global Quality vision and strategy, ensuring that the organization adheres to the highest standards of quality and compliance throughout the drug development process. 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 to quality (CtQ) data, processes, and vendors, as well as developing risk mitigation strategies that are integrated into protocols and 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 and compliance governance, 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 meaningful data and information are provided for oversight. The Senior Director will also be responsible for managing CAPAs from deviations, audits, inspections, and quality events, delivering expert root cause analysis and ensuring effective tracking and metrics for CAPA performance. Additionally, the Senior Director will coordinate R&D Quality Leadership Team meetings, act as the main point of contact for Global Quality Strategy and Business Excellence, and lead the development of the overall R&D Quality strategy and roadmap. This role is essential for ensuring that R&D Quality aligns with Global Quality strategies and initiatives, ultimately contributing to the success of Bristol Myers Squibb's mission to transform 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 protocols and operational plans.
• Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt operational and quality plans accordingly.
• Provide quality and compliance consultation to clinical trials teams throughout the study lifecycle.
• 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, delivering expert root cause analysis capabilities.
• Coordinate and support R&D Quality Leadership Team meetings, ensuring rigor in cadence, agenda, actions, and follow-up.

Requirements

• Minimum of BA/BS degree or in a life science discipline; advanced education preferred.
• Minimum 15 years 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.
• Excellent communication skills, both verbal and written, with strong presentation skills.

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