Director, CAPA Strategy, Insights & Risk Management

Bristol Myers Squibb • Devens, MA

26d • Hybrid

About The Position

The Director of the Corrective and Preventive Action (CAPA) Strategy, Insights and Risk Management will be responsible to lead a global end-to-end CAPA operating model across R&D. This role will drive strategic oversight of CAPA processes, ensure timely and effective resolution of quality issues, and leverage data-driven insights to identify systemic risks and opportunities for continuous improvement. The position will also lead the development of predictive risk management strategies, enable proactive quality interventions and strengthen inspection readiness across the enterprise aligned to ICH E6(R3)/E8(R1) and other global regulations. The role partners with key stakeholders across Research, Drug Development and Quality functions.

Requirements

• B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
• Subject matter expertise in Drug Development standards, regulators, procedures and best practices.
• Minimum 10+ years of GxP CAPA Management experience in Quality, Clinical Development or Regulatory Compliance.
• Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance.
• Extensive experience in CAPA Management and Serious Breach reporting requirements.
• Very experienced in Nonclinical, Clinical and Pharmacovigilance processes.
• Good understanding of BMS’s therapeutic areas - ICN and HOCT.
• Demonstrated analytical and conceptual capability—including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data.
• Proven track record of leading and managing cross-functional teams.
• Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution.
• Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication.
• Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
• Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies.
• Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.
• Ability to drive change and foster a culture of continuous improvement.

Responsibilities

• Provide vision and define the global CAPA strategy and governance model for Research & Development by establishing standard methods, templates, taxonomies, and escalation pathways for quality events, audits/inspections, and significant non-compliances.
• Design and implement a global CAPA governance framework aligned with regulatory expectations and internal quality standards.
• Ensure CAPA processes are risk-proportionate, timely, and effective, with robust root cause analysis, sustainability checks and support risk-signal detection.
• Oversee CAPA lifecycle management, including initiation, investigation, approval, implementation, and closure.
• Drive harmonization of CAPA processes across R&D functions and ensure integration with enterprise quality systems.
• Serves as a subject matter expert on Drug Development related regulations, standards, and best practices.
• Collaborate with RDQ Global Capability Center Lead, delivers strategic leadership in supervising CAPA oversight, ensuring that all CAPA-related performance metrics under GCC’s responsibility are effectively managed.
• Collaborates with key stakeholders across BMS, including Senior Vice Presidents / Vice Presidents within Research, Drug Development and Quality functions to influence stakeholders, drive accountability and CAPA ownership at all levels.
• Support inspection readiness, audits, and regulatory interactions related to CAPA, as needed
• Lead continuous improvement initiatives to enhance CAPA effectiveness and cycle times.
• Co-ordinate and delivers training programs, as needed, to enhance the understanding and effectiveness of the CAPA process across the organization.
• Serve as Operational Lead for Serious Breach Review Committee and guide cross-functional teams with the investigation and CAPA plan development.
• Oversee the identification, documentation, and reporting of serious breaches in compliance with regulatory requirements and company policies, ensuring timely and accurate communication to relevant authorities and stakeholders.
• Develop and maintain CAPA performance dashboards and metrics to monitor effectiveness and identify trends.
• Utilize advanced analytics to detect systemic issues, recurring deviations, and emerging risks.
• Provide actionable insights to senior leadership and governance forums to inform strategic decisions and resource allocation.
• Champion Digital Transformation and Innovation in CAPA Insights and Analytics.
• Design and maintain CAPA dashboard / metrics platform to facilitate signal detection, trend analysis, and drive proactive decision-making and prevention strategies.
• Generate and publish periodic CAPA insights to relevant R&D Governance Forums, for example – CAPA, Hub & Spoke; R&D Quality Council; Therapy Area PODs, etc.
• Provide strategic leadership to translate signals into prevention strategies, SOP updates, updates to training curricula, etc.
• Translate CAPA data into actionable insights to identify systemic issues, recurring risks, and improvement opportunities.
• Ensures effective communication and reporting of CAPA activities and outcomes to senior management and relevant stakeholders across R&D and Global Quality to provide executive-level reporting and recommendations.
• Develop a risk-based CAPA strategy aligned with ICH E6(R3) and ICH E8(R1), integrating quality-by-design principles, proactive risk identification, and prevention-focused actions to ensure effective issue remediation and sustained GCP compliance across the clinical lifecycle.
• Generate strategic insights from CAPA and quality data through trend analysis and risk signal detection to inform continuous improvement, support clinical risk management, and enable data-driven decision-making that enhances trial quality, subject protection, and inspection readiness.
• Leverage data and insights from instream quality assurance checks performed by Development Quality, significant non-compliances, audits, inspections, GCP deviations, and KPIs to identify systemic issues, emerging risks, and opportunities for improvement.
• Lead the adoption and integration of advanced digital tools, analytics platforms, and automation solutions to transform CAPA and risk management processes.
• Drive innovation by piloting new technologies (e.g., predictive analytics, AI-driven signal detection) and scaling successful initiatives across R&D Quality.
• Integrate risk signals from CAPAs (audits, inspections etc.), and operational KPIs into predictive models for proactive intervention.
• Establish and nurture strategic partnerships with external organizations, industry consortia, and regulatory bodies to benchmark CAPA and risk management practices.
• Represent the company at key industry forums, sharing internal learnings and bringing back best practices to inform process evolution and governance updates.
• Lead cross-company benchmarking initiatives to identify gaps, set stretch targets, and accelerate the adoption of innovative solutions.
• Collaborate with cross-functional teams, including but not limited to GPOs and the Business Process Council, to ensure the timely and effective resolution of quality issues, and to share lessons learned and best practices.
• Foster a culture of quality and continuous improvement within the organization.
• Track the external landscape and stay informed about industry practices and new regulations

Benefits

• Medical, pharmacy, dental, and vision care.
• Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• 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.
• 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: Director
• Number of Employees: 5,001-10,000 employees