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Senior Manager, Audit Intelligence Coordinator
Senior Manager, Audit Intelligence CoordinatorBristol-Myers Squibb • East Dublin, GA, US
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Senior Manager, Audit Intelligence Coordinator

Senior Manager, Audit Intelligence Coordinator

Bristol-Myers Squibb • East Dublin, GA, US
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Working with Us

Challenging. Meaningful. Life-changing. Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You'll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives. Read more : careers.bms.com / working-with-us.

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 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 & Experience

  • 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.
  • GPS_2025 GQ_2025

    If you come across a role that intrigues you but doesn't perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career.

    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 (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee's work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

    Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit careers.bms.com / life-at-bms / .

    Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following : 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, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility / infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

    Uniquely Interesting Work, Life-changing Careers

    With a single vision as inspiring as "Transforming patients' lives through science™ ", every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

    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 your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function.

    BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations / adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation / adjustment prior to accepting a job offer. If you require reasonable accommodations / adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com / eeo-accessibility to access our complete Equal Employment Opportunity statement.

    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 area.

    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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