Audit Manager GMP/GDP Internal Audits

Profile

Bristol-Myers Squibb is a global Biopharma company committed to a single mission: to discover, develop, and deliver innovative medicines focused on helping millions of patients around the world in disease areas such as oncology, cardiovascular, immunoscience and fibrosis.

Join us and make a difference. We hire the best people and provide them with a work environment that places a premium on diversity, integrity, collaboration and personal development. Through a culture of inclusion, we create a better, more productive work environment. We believe that the diverse experiences and perspectives of all our employees help to drive innovation and transformative business results.

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 best in class operation 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.

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 the resources to pursue their goals, both at work and in their personal lives.

Bristol-Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability or protected veteran status.

Company info

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