Director, CAPA CoE

Job Title:

CAPA Manager

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment.

• Lead the development, implementation, and maintenance of a robust CAPA program to ensure effective root cause analysis, CAPA planning, and compliance with regulatory requirements and industry best practices.
• Responsible to deliver expert root cause analysis capabilities in support of significant quality issue investigations and action plans.
• Responsible for CAPA oversight, ensuring clear tracking and metrics to drive on time performance.
• Monitor and analyze trends to identify areas for improvement and aimed at driving effectiveness and simplification.
• Ensure rigor in conducting thorough investigations, root cause analysis, and developing effective corrective and preventive actions.
• Develop and deliver training programs to enhance the understanding and effectiveness of the CAPA process across the organization.
• Ensure effective communication and reporting of CAPA activities and outcomes to senior management and relevant stakeholders.

Serious Breach Management:

• Enhance and streamline the serious breach reporting process to drive efficiency, eliminate waste, and facilitate clear, timely communication and trend analysis.
• 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.
• Lead cross-functional teams in the investigation and resolution of serious breaches, implementing corrective and preventive actions to mitigate risks and prevent recurrence.
• Monitor and analyze trends to identify potential risks and areas for improvement in a proactive manner.

Other Responsibilities:

• Line management responsibility to oversee team performance, provide guidance and development opportunities, ensuring operational efficiency and alignment with departmental and organizational objectives.
• 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.
• External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.
• Act as a highly credible technical/functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or crosslines.
• May influence the external environment through interactions with regulators, trade associations, or professional societies.
• Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.

Qualifications & Experience:

• B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
• Minimum 10 years of GxP CAPA Management experience in Quality, Clinical Development or Regulatory Compliance

Required Competencies:

• 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.
• Communication Skills: 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.
• Project Management: 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.