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Position Summary
The Associate Director of Specialty Laboratory Quality is responsible for effective management of the GLP/GCLP/GCP specialty laboratory audit program, with an emphasis on risk-based management, regulatory strategy development (i.e., fit-for-purpose), and monitoring the regulatory landscape.
Key Responsibilities:
Maintain 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 policies and procedures associated with laboratory research and development.
Provide advice and counsel concerning GLP and GCPregulatory requirements and GCLP principles. Monitor emerging issues and identify solutions.
Assist in managing the LQA audit program, including development of audit strategy and priorities and allocation of resources.
Keep management informed of issues that could have an impact on the audit program.
Assist in the development and advancement of policy and procedures to establish a compliant quality culture.
Conduct GLP/GCP/GCLP audits and inspections of laboratory-based studies for the purpose of assessing compliance with governmental regulations and established operating procedures:
Review study protocols, amendments and deviations.
Schedule and conduct audits of laboratory systems and study activities
Prepare and submit written audit reports.
Perform GLP/GCP/GCLP 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.
Maintain NCQ audit database, perform trending analysis of findings and identify opportunities for continuous improvements.
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.
Assist in the preparation of departmental standard operating procedures.
Provide inspection support during health authority inspections and CAP accreditation visits. Review potential findings and make recommendations for adequate and timely completion of corrective and preventive actions.
Coordinate and participate in regulatory training (e.g., GCP/GCLP training) of personnel involved in the conduct of laboratory biospecimen analysis.
Represent BMS within trade and professional associations
Provide input into BMS positions on responses to regulatory initiatives/proposals
Assume management responsibility for the LQA Specialty Laboratory QA function in the absence of senior management.
Adherence to BMS core behaviors
Qualifications & Experience
University graduate (science degree preferred)
At least 5 years audit experience or experience in a GLP, GCP/GCLP regulated environment
At least 8 years’ experience in the biopharmaceutical industry or related technical field.
At least 4 years’ experience supervising others or leading teams.
Daily collaboration and potential mentoring of other LQA auditors in the preparation, conduct, reporting and follow-up of audits and inspections.
Regular contacts with technical, supervisory, and management personnel in the conduct and reporting of internal audits and inspections.
Interaction with scientific and managerial personnel at contract research organizations during the evaluation of these facilities.
Close working relationship with external auditors and inspectors (FDA, USDA, etc.) during the conduct of their inspections.
Close working relationship with LQA senior management
Collaboration with external colleagues and trade associations.
Mastery of GLP & GCP regulatory requirements and principles of GCLP
Thorough technical knowledge/experience in the fields related to LQA oversight and providing regulatory counsel.
Effectively communicates verbally and in writing and able to impact and influence people.
Strong critical thinking to analyze complex situations and discern critical issues Commitment to Quality
Able to analyze and interpret complex problems/data gathered from a variety of sources and summarizing complex issues to stakeholders.
Able to meet high quality requirements within tight deadlines and adapt to changing priorities.
Works effectively with a range of technically and culturally diverse people, including regulatory agency personnel.
Supervisory, project management and organizational skills
Experience with regulatory authorities and providing guidance to senior management on regulatory issues.
Approximately 10% travel may be required in this position. These trips will include travel to BMS sites and contract research organizations to conduct audits and to attend professional meetings and seminars.
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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
BMS has a diverse 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/
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