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. 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

Reporting to the Senior Director, Competitive Compliance, the Associate Director, Vendor Audits, manages the relationship with the third-party service provider conducting audits for BMS. The Associate Director also acts as a liaison with External Manufacturing, the GMP/GDP audit team, and Predictive Quality to align audit plans and governance with risk-based principles, collaborating on risk mitigation strategies to ensure compliance.

Key Responsibilities:

Manage the relationship with and oversee the third-party service provider conducting audits of external parties for BMS, including routine GMP/GDP audits, for-cause and preliminary evaluation audits of raw material, product and service providers.
Act as the primary point of contact for the third-party service provider concerning quality and compliance issues, conduct periodic strategy review meetings, manage escalations, review audit dashboards, and collaborate to resolve any quality-related concerns or issues.
Ensure the third-party service provider’s audit reports, findings, and action plans adhere to BMS quality standards and to both global and local regulatory requirements.
Identify opportunities for process improvements within the third-party service provider audit and management program, and implement best practices and innovative solutions to enhance the efficiency and effectiveness of the program.
Act as the liaison with External Manufacturing and the GMP/GDP Audit Team, ensuring the global GMP/GDP audit plan and governance is logical, effective, and aligned with risk-based principles. Accurately identify and assess inherent risks to ensure a thorough evaluation of potential issues throughout the audit process.
Ensure appropriate rigor and governance of critical suppliers as it relates to the audit program.
Partner with the Predictive Quality team to gain insights into potential risks associated with contract manufacturing organizations (CMOs). Collaborate with External Manufacturing to develop and implement strategies that mitigate these identified risks, ensuring continuous improvement and reliability of manufacturing processes.
Alert upper management and stakeholder organizations of potential compliance issues, like refused audits or critical/repeat observations in a timely manner.
Utilize automation and predictive analysis tools to monitor industry trends and stay updated on evolving regulations, ensuring compliance, enabling the identification and prediction of potential risks.
Plan, organize and conduct audits to the defined global GMP/GDP audit program, as required.
Partner with Inspection Readiness in conducting mock pre-approval inspections (PAIs) at CMOs.

Qualifications & Experience:

Bachelor’s degree in Natural Science, Pharmacy, or related fields, required.
A minimum of eight (8) years’ experience in the Biopharm/Pharmaceutical industry with in-depth knowledge and experience in global auditing procedures and best practices.
Demonstrated negotiation, risk management, relationship management and conflict resolution skills.
Proven ability to understand complex processes/problems and propose alternate solutions.
Demonstrates innovation, flexibility, open-mindedness, and adaptability to meet objectives in a rapidly changing environment with shifting priorities.
Demonstrated ability to work in a matrixed organization with a range of technically, culturally, and geographically diverse teams and to influence areas not under direct control to achieve objectives and effectively communicate challenging goals and objectives.
Able to complete multiple, simultaneous projects with minimal supervision and prioritize incoming work appropriately.
Has a proven track record of working across the network to find common solutions and drive positive impact and benefits for patients.
In-depth knowledge of Global Health Authority regulations, quality systems principles and applications to the pharmaceutical industry.
Ability to communicate and collaborate with employees and management at all levels and through various formats (e.g. presentations, written proposals, reports, correspondence, lead meetings, face-to-face dialogue, etc.)
Proficiency in gathering insights from data analytics and advanced analytics tools.

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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.

Compensation Overview:

Devens - MA - US: $175,310 - $212,438 New Brunswick - NJ - US: $163,850 - $198,543 Princeton - NJ - US: $163,850 - $198,543

The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job, such as required skills, where the job is performed, the employee’s work schedule, job-related knowledge, and experience. Final, individual compensation will be decided based on demonstrated experience.

Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit https://careers.bms.com/life-at-bms/.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program.

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 a supportive culture, promoting global participation 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 an 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/

Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.

Associate Director, Vendor Audits

Benefits

Job Description