Manager, Good Laboratory Practice (GLP) Auditing

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 rich in diversity. 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 The Manager of GLP Auditing will inspect and audit each nonclinical laboratory safety study to assure quality and compliance with Good Laboratory Practice (GLP) and other applicable regulations and departmental procedures. Audits of internal processes critical to the conduct of nonclinical laboratory studies and contract research organizations used for the conduct of GLP studies are also responsibilities of Nonclinical Quality (NCQ) as well as assisting stakeholders with regulatory advice and preparation for regulatory agency inspections. Key Responsibilities and Major Duties: Continue to develop an in-depth knowledge of governmental regulations which impact upon the research and development of medicines as well as the most relevant Bristol Myers Squibb Company policies and procedures associated with preclinical research. Conduct GLP audits and inspections of preclinical studies for the purpose of assessing compliance with governmental regulations and established operating procedures: Review study protocols, amendments, and deviations. Schedule and conduct inspections of study activities. Prepare and submit written reports of these inspections to study director and management. Audit final reports and raw data for these studies. Perform GLP systems audits at various BMS sites and/or functional areas, as well as at contract research organizations, for the purpose of assessing regulatory compliance: Compile documentation in preparation for the audit. Prepare clearly written, accurate, and evidence-based audit reports to effectively communicate the audit findings to the auditees and management. Review and assess corrective action plans and follow-up on the resolution of audit findings. Keep clear and detailed documentation on every audit planned, performed, and followed. Regularly update the NCQ audit database, generate, review and maintain required reports (e.g., master schedule, findings reports, etc.). Perform trending analysis of findings as required. Assist in the preparation of departmental standard operating procedures. Participate in preparation and conduct of regulatory training (e.g., GLP training) of personnel involved in the conduct of preclinical studies. Key Requirements: Minimum Bachelors degree required; Life Sciences Degree preferred Experience in GLP regulated environment; knowledge and understanding of the regulatory framework Experience with GLP auditing and inspections is strongly preferred; Computer System Validation (CSV) auditing experience is a plus Knowledge of study protocols, amendments, and deviations Ability to work independently and clearly communicate audit findings to the auditees and management Ability to interact with Health Authorities such as the FDA and USDA with illustrated knowledge of Animal Welfare Practices, Controlled Substances, and other regulatory guidelines
LI-Hybrid 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. 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 an inclusive culture, promoting diversity 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 Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. COVID-19 Information 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. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.