Bristol-Myers Squibb Company

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

Bristol-Myers Squibb is seeking an Associate Director, Principal Product Quality Leader (PQL), in Global Product Quality to support commercial projects within the Cell Therapy organization. The PQL will be responsible for overseeing the lifecycle management of a commercial cell therapy product. The PQL will provide direct technical and quality compliance oversight of the commercial program (vector, gene editing and cell therapy projects) to ensure regulatory compliance of GMP operations in support of the program.The PQL must drive alignment across cell therapy programs that are appropriate for a commercial program along with associated regulatory expectations and global compliance requirements. The individual will provide technical expertise and leadership to Product CMC/Quality Teams to develop, implement, and manage the strategies for Quality to meet product goals. The PQL will develop and roll-out product quality frameworks relating to end-to-end Quality management of commercial manufacturing, life-cycle improvements and control strategies. The PQL is a matrixed leader able to plan for strategic implementation of commercial requirements while supporting the progress of the program in the rapidly evolving cellular therapeutic field. The Product Quality Leader has responsibility for working directly with QC, QA, Manufacturing, Stability, Analytical Development, Process Development, Manufacturing Sciences and Technologies, Regulatory Affairs, and other Cell Therapy Development Organizations on the resolution of issues associated with process/manufacturing, control strategy, analytical methods, specifications, reference standards, stability, investigations, change control, product complaints, and regulatory submissions. The PQL has oversight and decision authority over multiple aspects of the cell therapy program including analytical and process lifecycle changes, regulatory submissions, and health authority communications.

Key Responsibilities

• Provide global product quality oversight and support for external manufacturing / partnerships and internal manufacturing operations including developing and maintaining relationships with site QA, QC, analytical and process development, manufacturing sciences and technology, and regulatory affairs functions.
• Supports the overall product quality strategy based on CMC deliverables, technical team objectives, life-cycle improvements, and regulatory commitments.
• Provides technical quality expertise and compliance oversight in accordance with global regulatory requirements and internal policies in support of life-cycle management activities.
• Review clinical and commercial regulatory filings as needed.
• Demonstrate the ability to influence others through persuasive interactions and garner support for novel solutions where applicable.
• Show the capacity to operationalize theoretical concepts into actionable plans and execute those plans with successful outcomes.
• Chairs the Analytical Subteam meetings between Site QA/QC, Analytical Development, Process Development, Manufacturing Sciences and Technology, Product Sciences, and Regulatory Affairs.
• Coordinates program specific presentations to the Product Quality Review Board / Product Specification Committee and other product quality related cross-functional teams
• Serves as QA reviewer / approver for analytical and process protocols and reports, stability protocols and reports.
• Owner of product release and stability specifications and strategy
• Provide strategic guidance and facilitate the timely implementation of global changes with respect to the assigned product. Owns global changes and documentation management activities as required.
• Assist in the continuous improvement and lifecycle management of GMP operations, including providing guidance and direction for transitioning from clinical to commercial phase
• Serves as quality oversight for product and stability trend investigations

Qualifications

• BS/MS in relevant Science or Engineering discipline and 10+ years of experience in Quality in a biotech, pharmaceutical, or bio-pharmaceutical organization; 1-3 years of experience in a supportive PQL role is preferred
• Expertise is Lentiviral Vector manufacturing or analytics with validation experience is a plus.
• Expertise in GMP compliance, global regulations and strong understanding of pharmaceutical product development lifecycle are required.
• Experience with review of market applications, IND, supplements or similar regulatory documentation is required.
• Demonstrated technical skillset with analytics and/or process development is preferred
• Demonstrated ability in decision making and problem solving is required
• Demonstrated Quality leadership through partnership in a matrixed-organization is required
• Background in Vaccines, Biologics, or Cell Therapy Manufacturing is required
• Demonstrated ability to work cross-functionally and to develop and maintain strong business partner relationships
• Proven leadership ability to carry out difficult decisions in a logical, rational manner, and demonstrated ability to work as a senior management team member and to engage and influence team members in a matrixed environment
• Must be able to effectively operate and deliver in a continuously evolving regulatory and operations landscape.

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: $174,260 - $211,160 Madison - Giralda - NJ - US: $162,860 - $197,348 Seattle - WA: $179,140 - $217,073

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 in effect at the time and may require enrollment. Our benefits include:

• Health Coverage: Medical, pharmacy, dental, and vision care.
• Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
• Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.

Work-life benefits include:

Paid Time Off

• US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees)
• Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays

Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

All global employees full and part-time who are actively employed at and paid directly by BMS at the end of the calendar year are eligible to take advantage of the Global Shutdown.

• Eligibility Disclosure: The summer hours program is for United States (U.S.) office-based employees due to the unique nature of their work. Summer hours are generally not available for field sales and manufacturing operations and may also be limited for the capability centers. Employees in remote-by-design or lab-based roles may be eligible for summer hours, depending on the nature of their work, and should discuss eligibility with their manager. Employees covered under a collective bargaining agreement should consult that document to determine if they are eligible. Contractors, leased workers and other service providers are not eligible to participate in the 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.

Supporting People with Disabilities

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.

Candidate Rights

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/

Data Protection

We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection.

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

If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley.

R1597688 : Associate Director, Principal Product Quality Lead

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