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.
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.
B.S. or advanced degree in a science or biopharmaceutical-related field.
Minimum of 10 years’ experience in the Biopharmaceutical Industry, and > 5 years in a GMP/GDP independent auditing role.
Demonstrated auditor experience interacting with global vendors, suppliers and CMOs.
Direct experience leading and conducting GMP/GDP audits and pre-approval inspections of Drug substance, Drug product, Biologics or Medical Device facilities.
Demonstrated technical writing and communication experience for detailed audit reports, investigation and summary reports.
Significant experience and technical knowledge in three or more of the following areas: Biopharmaceutical Manufacturing, Quality Assurance; Validation, Quality Control, Biotechnology, Facility & Utilities, Materials Management.
Key Competency Requirements
Ability to think clearly and act in a decisive manner; communicate difficult observations in a calm and cogent manner.
Demonstrated ability to work independently or with groups of people/teams in a complex changing environment.
Adaptable/flexible and able to deal with change.
Enterprise mindset and external focus.
Demonstrated negotiation, risk management, relationship management and conflict resolution skills.
In-depth knowledge of Global HA regulations, quality systems principles and applications to the pharmaceutical industry.
Highly developed conceptual and analytical skills that support the ability to audit, investigate, and advice on problem resolution across a wide variety of quality/operational processes and practices.
Up to 50 % travel time required per year to any region (Americas, Europe, Asia, etc.)
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.