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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.
Position Summary
The Associate Director of Specialty Laboratory Vendor Quality will be mainly responsible for implementing the strategy for GCP/GCLP/GLP specialty laboratory (i.e., biomarker) vendors from a quality perspective and delivering the full range of quality. This role reports directly to the Director, Specialty Laboratory Quality.
Key Responsibilities:
Support independent quality vendor oversight through audits and inspections
Implement the quality strategy for Specialty Laboratory Vendors:
Assess and manage specific risk areas associated with clinical vendors
Partner with the business/cross functional teams to establish and monitor quality KPIs, addressing issues proactively
Drive continuous quality process improvements/oversight initiatives to enhance quality efficiency and compliance
Create a quality narrative summarizing the result of evidence of quality activities related to vendor oversight and data integrity
Support independent vendor quality oversight:
Provide direction and oversight to the vendor qualification and audit program to ensure regulatory compliance
Develop the audit strategy for clinical laboratory vendor audits, including audit scope to assess the vendors risk, quality systems, capabilities and performance
Supports the development of clinical laboratory Quality Agreements and the set-up of the respective quality governance
Co-Manages QA-to-QA relationship with preferred/critical CROs and vendors
Audits and Inspections:
May conduct GCP/GCLP/GLP audits and inspections at various BMS sites and/or functional areas, and contract research organizations, depending on departmental resource needs
Engage in activities to support product submission, registrational filings and inspections
Qualifications & Experience:
B.S. and/or M.S. in Chemistry, Biology, IT or Health related
Minimum 5 years QA experience or relevant experience in medical quality management, biomedical science, clinical development, or regulatory compliance
Specific Knowledge:
Demonstrated strong knowledge of GCP/GCLP/GLP regulatory requirements and guidelines as they related to the analysis of clinical trial biospecimens.
Clinical research processes and principles of Quality Assurance
Demonstrated ability to work in an international environment leading global quality functions.
Knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management.
Communicates professionally, clearly, concisely, and consistently both verbally and in writing to internal and external stakeholders.
Excellent presentation skills for compelling peer and Senior Management communication.
Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.
Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies.
Approximately 20% travel may be required in this position.
#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
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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