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 Director, GMP and GDP Audits is responsible for developing and implementing a strategic global audit program to proactively identify risk areas while aligning with company objectives and regulatory requirements. They will lead and mentor a team of auditors, ensuring their continuous development and adherence to industry regulations and best practices. This role involves managing resources effectively, overseeing audit processes for internal and external sites, and leveraging technology to standardize audit reporting. The Director will collaborate with various departments and senior management, providing expert guidance on regulatory compliance and audit findings. Additionally, they will focus on continuous improvement by identifying process enhancements and ensuring the effectiveness of training programs for auditors and stakeholders.
Key Responsibilities:
Integrate the global perspectives to achieve the optimal audit strategy in accordance with company objectives to proactively identify risk areas.
Lead, mentor, and develop a team of GMP/GDP auditors, fostering a culture of continuous improvement and professional growth.
Manage and re-direct resources as necessary to assure that the company strategy and objectives are achieved.
Oversee the training, performance evaluation, and continuous development of GMP/GDP auditors. Ensure the audit team stays current with industry regulations, guidelines, and best practices related to GMP/GDP.
Implement and oversee a comprehensive GMP/GDP audit program for both internal and external sites, in alignment with regulatory requirements and company policies.
In collaboration with Predictive Quality, ensure alignment and proper deployment of annual audit plan.
Ensure timely and accurate reporting of audit findings and follow-up actions, leveraging technology and automation to standardize report writing and audit agendas.
Provide expert guidance on regulatory requirements and ensure the audit program is aligned with BMS standards as well as global and local regulatory guidelines.
Identify opportunities for process improvements within the audit program and implement best practices.
In partnership with the Training team, develop and deliver training programs to enhance the knowledge and skills of the audit team, leveraging industry best practices and auditor qualification program.
Monitor and evaluate the effectiveness of audit qualification program and training.
Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Supply Chain, and Regulatory Affairs, to ensure alignment and support for audit activities.
Plan, organize and conduct audits to the defined global GMP/GDP audit program, as required.
Communicate audit results, trends, and risks to senior management and provide recommendations for improvement.
Alert upper management and stakeholder organizations of potential compliance issues, like refused audits or critical/repeat observations in a timely manner.
Collaborate with industry colleagues through benchmarking of regulatory activities to establish a state-of-art program.
Potentially support key regulatory agency inspections of high risk and impact to the company, including review of findings and providing input into BMS position on inspection responses.
Qualifications & Experience:
Bachelor’s degree in Natural Science, Pharmacy, or related fields, required.
A minimum of ten (10) years’ experience in the Biopharm/Pharmaceutical industry with in-depth knowledge and experience in global auditing procedures and best practices.
A minimum of five (5) years leadership experience managing Audit teams.
Demonstrated ability to lead and manage effective teams.
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.
Strong communication, collaboration, negotiation, problem solving and interpersonal skills.
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 gaining insights from data analytics and advanced analytics tools.
The ideal candidate should have experience participating in Health Authority inspections and, preferably, have worked for a Health Authority such as the FDA or other health authority agencies.
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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.
Devens - MA - US: $200,840 - $243,368
New Brunswick - NJ - US: $187,700 - $227,445
Princeton - NJ - US: $187,700 - $227,445
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/
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