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 across internal sites, global suppliers, and entities such as CMOs, APIs, raw materials, and external labs. Plans, organizes, and schedules audit assignments in alignment with the global audit plan and supports due diligence audits for clinical and commercial 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, due diligence audits, PAI readiness, directed or for-cause audits, acquisitions, regulatory/distributor considerations, labeling, and inspection readiness.
• Leverage digital solutions such as automation and AI to enhance efficiency in audit planning and focus on high-impact areas.
• Communicate global audit plan changes with stakeholders, Audit Operations, lead auditors, and audit outsourcing partners promptly.
• Periodically review and update the audit plan using current compliance, quality, data intelligence, and risk-based principles.
• Document, justify, and approve exceptions to the global audit plan.
• Stay current with regulations affecting the Audit program and modify plan, policies, and directives to maintain appropriate compliance.
• Maintain and continuously improve governing procedures and processes.
• Develop and utilize metrics and analyses to monitor health and performance of the Audit program, enhance planning, and measure outcomes/impacts of audits.
• Elevate and refine the audit program through data-driven insights in partnership with Competitive Compliance.
• Utilize Quality Risk Management (QRM) and the Quality Council to communicate signals, mitigate risks, and drive continuous improvement.
• Obtain business support to resolve supplier audit scheduling issues, including audit refusal or audit fees.

Qualifications

• Minimum five (5) years of experience in biopharmaceutical manufacturing, quality, technical, or regulatory roles, or with a regulatory health authority; strong auditing, metrics, analysis, and business analytics background.
• Bachelor's degree in pharmaceutical sciences, engineering, biology, or related disciplines required.
• Ability to understand complex processes and propose alternative solutions.
• Demonstrates innovation, flexibility, and adaptability to changing priorities.
• Strong communication, collaboration, negotiation, problem-solving, and interpersonal skills.
• Experience working in a matrixed organization with diverse teams and ability to influence without direct authority.
• Ability to manage multiple projects with minimal supervision and prioritize workload.
• In-depth knowledge of global health authority regulations and quality systems in the pharmaceutical industry.
• Proven track record of cross-network collaboration to drive positive patient impact.
• Understanding of performance/health program monitoring and data quality assurance principles.
• Effective communication across levels and formats (presentations, proposals, reports, meetings).
• Proficiency in data analytics and advanced analytics tools.

Skills

• Data analytics and advanced analytics tools
• Risk management and quality systems
• Stakeholder management and collaboration
• Auditing and regulatory compliance
• Process improvement and data-driven decision making

Education

• Bachelor's degree in pharmaceutical sciences, engineering, biology, or related disciplines

Additional Requirements

• On-site/occupancy requirements may vary by location and role design; travel requirements as applicable to audit activities.