Senior Manager, Audit Intelligence Coordinator

Role Summary

Senior Manager, Audit Intelligence Coordinator. Responsible for planning audits in support of the BMS Competitive Compliance Audit Program, coordinating audits for internal sites, global suppliers, and entities such as CMOs, APIs, raw materials, and external labs. Plans, organizes, and schedules audit assignments in accordance with the global audit plan and supports due diligence audits for clinical and commercial business developments. Utilizes data-driven insights to enhance audit planning and execution and integrates with internal processes such as QRM and Quality Council.

Responsibilities

• Develop and implement an annual audit plan using risk-based principles and data-driven decision-making.
• Plan, organize, and schedule audit assignments in collaboration with Audit Operations, in accordance with the defined audit program and audit plan.
• Maintain and update the annual audit plan for planned and unplanned changes including routine audits, due diligence audits, PAI readiness, directed or for-cause audits, acquisitions, regulatory/agent distributors, labeling and inspection readiness.
• Enhance efficiency of the audit planning process by leveraging digital solutions such as automation and AI to advance strategic initiatives.
• Communicate global audit plan changes to stakeholders, Audit Operations, lead auditors, and audit outsourcing partners in a timely manner.
• Periodically review and update the audit plan using current compliance, quality, data intelligence, and risk-based principles.
• Ensure exceptions to the global audit plan are properly documented, justified, and approved.
• Stay abreast of regulations affecting the Audit program and modify plans, policies, and directives to ensure compliance with changing requirements.
• Maintain and continuously improve governing procedures and processes.
• Develop metrics and analysis to monitor the health and performance of the Audit program, enhance planning, maximize effectiveness, and measure outcomes.
• Elevate and refine the audit program through data-driven insights in partnership with Competitive Compliance.
• Utilize Quality Risk Management (QRM) and Quality Council to communicate signals, mitigate risks, and drive continuous improvement.
• Support the business in supplier audit scheduling issues, including audit refusals and audit fees.

Qualifications

• Minimum of five (5) years' experience in biopharmaceutical Manufacturing, Quality, Technical, or Regulatory roles or experience with regulatory health authorities; strong understanding of auditing, metrics, analysis, and business analytics.
• Bachelor's degree in pharmaceutical sciences, engineering, biology, or related disciplines, required.
• Ability to understand complex processes and propose alternative solutions.
• Innovation, flexibility, adaptability to rapid change and shifting priorities.
• Strong communication, collaboration, negotiation, problem-solving, and interpersonal skills.
• Experience working in a matrixed organization with diverse teams and influencing across boundaries.
• Capacity to manage multiple projects with minimal supervision and prioritize work.
• In-depth knowledge of Global Health Authority regulations and quality systems principles as applied to pharma.
• Proven track record of cross-network collaboration to drive positive impact for patients.
• Strong understanding of performance/health program monitoring and data quality assurance.
• Ability to communicate and collaborate with stakeholders at all levels using various formats.
• Proficiency in data analytics and advanced analytics tools.

Skills

• Data analytics
• Auditing and regulatory compliance
• Quality risk management (QRM)
• Stakeholder management
• Process improvement
• Program management

Education

• Bachelor‚Äôs degree in pharmaceutical sciences, engineering, biology, or related disciplines, required.

Additional Requirements

• On-site or hybrid work as determined by role; willingness to travel as needed to coordinate audits.