Senior Manager, Audit Intelligence Coordinator
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Position 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.
Key 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 improve 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 are not limited to audit refusal and/or audit fees.
Qualifications & Experience
* A minimum of five (5) years’ experience in the biopharmaceutical industry in a Manufacturing, Quality, Technical, or Regulatory position, 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.
Compensation Overview
Devens – MA – US: $152,530 – $184,834. New Brunswick, NJ – US: $142,550 – $172,741. Princeton, NJ – US: $142,550 – $172,741. The starting compensation range(s) for this role are listed above for a full‑time employee (FTE) basis. Additional incentive cash and stock opportunities may be available based on eligibility. The starting pay rate takes into account characteristics of the job, such as required skills, location, schedule, and experience. Final individual compensation will be determined based on demonstrated experience.
Benefits
Medical, pharmacy, dental, and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial wellbeing resources and a 401(k). Insurance and benefits for life, disability, and other. Paid national holidays and optional holidays, global shutdown days, up to 120 paid vacation hours, up to two paid days to volunteer, sick time, summer hours flexibility, parental and caregiver leave, military leave, family care services, tuition reimbursement, and recognition program. For more on benefits, visit https://careers.bms.com/life-at-bms/.
On‑site Protocol
BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site‑essential, site‑by‑design, field‑based, and remote‑by‑design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role. Site‑essential roles require 100% of shifts onsite at the assigned facility. Site‑by‑design roles may be eligible for a hybrid work model with at least 50% onsite. For these roles, onsite presence is a critical job function. Field‑based and remote‑by‑design roles require the ability to travel to meet customers, patients, or partners as essential job functions.
Disability Accommodation
BMS is dedicated to ensuring people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations and ongoing support. Applicants can request accommodations prior to accepting an offer. For assistance, contact adastaffingsupport@bms.com. Visit https://careers.bms.com/eeo‑accessibility for full details.
Vaccination Policy
BMS strongly recommends that all employees be fully vaccinated for COVID‑19 and keep up to date with boosters.
Criminal Background
BMS will consider qualified applicants with arrest and conviction records in accordance with applicable laws in your area.
California Residency
If you live or expect to work from Los Angeles County for this position, visit https://careers.bms.com/california‑residents/ for important additional information.
Data Privacy
Any data processed in connection with role applications will be treated according to applicable data privacy policies and regulations.
Employee Well‑being
BMS cares about your well‑being and the well‑being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for COVID‑19 and keep up to date with COVID‑19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your region. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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