Job Description

At Bristol Myers Squibb, we are inspired by a single vision – transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease – and one of the most diverse and promising pipelines in the industry – each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to every treatment we pioneer. Join us and make a difference.

The Global GMP/GDP Internal Audit team is responsible for GMP/GDP audits across the BMS network (both for Commercial and Clinical trial products).  

This position supports the GMP/GDP Audit Program by performing audits of global business entities, which are owned and/or operated by BMS. 

The Audit Manager works collaboratively with other members of the "Regulatory Compliance and External Engagement" (RCEE) team, to evaluate GMP/GDP business operations for compliance with health authority requirements and corporate policies, to ensure product quality and patient safety.

General Responsibilities Include:

• Plan, organize and conduct audits in accordance with the Annual audit plan.
• Assure exceptions to the Master Audit Plan are properly documented and approved.
• Support business development by performing unplanned audits and mock pre-approval inspections (mPAI).
• Lead the development and execution of audit strategies, designed to assess compliance gaps and business risks for GMP/GDP operations at BMS internal sites, located worldwide.
• Generate timely audit reports that adequately convey deficiencies observed, the significance of the observations, and the level of risk that is posed to the business, as a result.
• Evaluate auditee responses to audit observations, and ensure that proposed CAPA plans are suitable to address the observed deficiency, and reduce risk to the business.
• Review evidence of CAPA completion, and evaluate CAPA effectiveness during subsequent audits.
• Lead and drive continuous improvement of the audit program, and development of tools and processes utilized to facilitate the audit process.
• Highlight risks & trends from the global audit program as necessary; through routine communication and escalation mechanisms.
• Perform all responsibilities in accordance with applicable company guidelines, SOPs and appropriate industry and regulatory standards, guidelines, rules and regulations.
• Maintain current knowledge of updated regulations; industry guidance; and best practices to ensure optimal execution of the audit program.  
• Support other duties as required.
• Adhere to BMS core behaviors, and align with corporate values.

This is intended to be a general job description and should not be considered as all-inclusive.

Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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. 

Physical presence at the BMS worksite or physical presence in the field is an essential job function of this role which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and enhances the Company culture.

To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation.  Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment.  This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S.

Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an approval of accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or if you are applying to a role based in the U.S. or Puerto Rico and you believe that you are unable to receive a COVID-19 vaccine due to a medical condition or sincerely held religious belief, during or any part of the recruitment process, please direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.