Senior Manager, Audit Intelligence Coordinator

Bristol-Myers Squibb • Princeton, NJ

76d • $142,550 - $184,834 • Hybrid

About The Position

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.

Requirements

• A minimum of five (5) years' experience in the biopharmaceutical industry in a Manufacturing, Quality, Technical, or Regulatory position or a combination thereof.
• High level understanding of auditing, metrics, analysis and Business Analytics.
• Bachelor's degree in pharmaceutical sciences, engineering, biology, or other related disciplines.
• 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.
• Strong communication, collaboration, negotiation, problem solving and interpersonal skills.
• Demonstrated ability to work in a matrixed organization with diverse teams.
• Able to complete multiple, simultaneous projects with minimal supervision.
• In-depth knowledge of Global Health Authority regulations and quality systems principles.
• Strong understanding of performance/health program monitoring and data quality assurance principles.
• Proficiency in data analytics and advanced analytics tools.

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.
• Enhance efficiency and simplify the management of the audit planning process by leveraging digital solutions such as automation and AI.
• 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 compliance with changing regulatory requirements.
• Maintain and continuously improve governing procedures and processes.
• Develop and utilize robust metrics and analysis to monitor the health and performance of the Audit program.
• Continuously elevate and refine the audit program through vigilant monitoring and data-driven insights.
• 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.

Benefits

• Medical, pharmacy, dental and vision care.
• Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
• Financial well-being resources and a 401(K).
• Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance.
• Work-life programs including paid national holidays, up to 120 hours of paid vacation, and sick time off.
• Parental, caregiver, bereavement, and military leave.
• Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits.
• Tuition reimbursement and a recognition program.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Bachelor's degree