Senior Manager, Audit Intelligence Coordinator

Role Summary

Reporting to the Senior Director, Operations & Performance, the Senior Manager, Audit Intelligence Coordinator, is responsible for planning audits in support of the BMS Competitive Compliance Audit Program. This includes coordinating audits for internal sites, global suppliers, and various entities such as CMOs, APIs, raw materials, and external labs. This role involves planning, organizing, and scheduling audit assignments in accordance with the global audit plan. It also supports clinical and commercial business developments through due diligence audits and communicates any changes in the global audit plan to stakeholders and audit outsourcing partners. Utilizing data-driven insights, this role aims to enhance audit planning and execution, ensure the audit program's health and performance, and integrate seamlessly 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 but not limited to routine, due diligence audits, pre-approval Inspection (PAI) readiness, Directed or For Cause, acquisitions, regulatory/agent distributors, labeling and inspection readiness.
• Responsible for enhancing efficiency and simplifying the management of the audit planning process by leveraging digital solutions such as automation and AI to advance strategic initiatives and focus on areas that drive the most impact.
• 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 the most 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 current and updated regulations affecting the Audit program. Make modifications to the plan, policies, and directives to ensure an appropriate level of compliance with the changing regulatory requirements.
• Maintain and continuously improves governing procedures and processes.
• Develop and utilize robust metrics and analysis to monitor the health and performance of the Audit program, enhance audit planning, maximize audit effectiveness, and measure outcomes/impacts of audits.
• Continuously elevate and refine the audit program through vigilant monitoring and data-driven insights, in strategic partnership with Competitive Compliance.
• Utilize internal processes such as Quality Risk Management (QRM) and the Quality Council to communicate signals and trends, mitigate risks, and drive continuous improvement.
• Obtain support from the business to deal with supplier audit scheduling issues - these issues include but not limited to audit refusal and/or audit fees.

Qualifications

• A minimum of five (5) years' experience in the biopharmaceutical industry in a Manufacturing, Quality, Technical, or Regulatory position or a combination thereof and/or working with a regulatory health authority. High level understanding of auditing, metrics, analysis and Business Analytics.
• Bachelor's degree in pharmaceutical sciences, engineering, biology, or other related disciplines, required.
• Proven ability to understand complex processes/problems and propose alternate solutions.
• Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
• Strong communication, collaboration, negotiation, problem solving and interpersonal skills.
• Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
• Able to complete multiple, simultaneous projects with minimal supervision and prioritize incoming work appropriately.
• In-depth knowledge of Global Health Authority regulations, quality systems principles and applications to the pharmaceutical industry.
• Has a proven track record of working across the network to find common solutions and drive positive impact and benefits for patients.
• Strong understanding of performance/health program monitoring and data quality assurance principles.
• Ability to communicate and collaborate with employees and management at all levels and through various formats (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)
• Proficiency in data analytics and advanced analytics tools.