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; supports due diligence audits; communicates changes to stakeholders and audit outsourcing partners; aims to enhance audit planning and execution using data-driven insights 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, and in accordance with the defined audit program and audit plan.
• Work with key stakeholders to maintain and update the annual audit plan for both planned and unplanned changes including routine, 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 with stakeholders, Audit Operations, lead auditors and audit outsourcing partners regarding global audit plan changes 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 the plan, policies, and directives to maintain appropriate compliance.
• Maintain and improve governing procedures and processes.
• Develop metrics and analysis to monitor health and performance of the Audit program, enhance planning, and measure outcomes of audits.
• Elevate and refine the audit program through monitoring and data-driven insights in partnership with Competitive Compliance.
• Utilize internal processes such as Quality Risk Management (QRM) and the Quality Council to communicate signals/trends, mitigate risks, and drive continuous improvement.
• Obtain support to address supplier audit scheduling issues (e.g., audit refusals, audit fees).

Qualifications

• Minimum five (5) years of experience in biopharmaceutical Manufacturing, Quality, Technical, or Regulatory roles or with a regulatory health authority; strong understanding of auditing, metrics, analysis, and business analytics.
• Bachelor's degree in pharmaceutical sciences, engineering, biology, or related disciplines required.
• Proven ability to understand complex processes and propose solutions.
• Innovative, flexible, adaptable to changing priorities; strong communication, collaboration, negotiation, problem-solving, and interpersonal skills.
• Experience in a matrixed organization with diverse teams; ability to influence without direct control and communicate goals clearly.
• Ability to manage multiple projects with minimal supervision and prioritize work effectively.
• Knowledge of Global Health Authority regulations and quality systems applicable to the pharmaceutical industry.
• Proven track record of cross-network collaboration to drive positive patient impact.
• Strong understanding of performance/health program monitoring and data quality assurance.
• Ability to communicate and collaborate with all levels of employees and management; proficient in data analytics and advanced analytics tools.

Skills

• Data analytics and advanced analytics tools
• Risk-based auditing and audit planning
• Stakeholder management and communication
• Process improvement and digital solutions (automation and AI)
• Quality Risk Management (QRM) and Quality Council processes

Education

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

Additional Requirements

• On-site requirements or travel expectations are not explicitly specified in the provided description. If applicable, follow internal policy for site-essential or hybrid work models.