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

 

The Senior Director, Cell Therapy Global Product Quality Lead (Sr. Dir. CT-GPQL) is accountable for delivering commercially robust and globally compliant quality strategies and outcomes that sustain the product supply chain throughout the product lifecycle. He/She manages product quality risk throughout the product lifecycle, including oversight of process and analytical lifecycle, control strategies, comparability, specifications, and stability. The Sr. Director monitors commercial operations through periodic reviews of process and method performance, including Annual Product Quality Reviews as well as provides general support and leadership within the Global Product Quality organization. The Sr. Director authors designated sections of regulatory filings, reviews all sections for clarity, technical persuasiveness, consistency and completeness, and serves as a subject matter expert and strategist during health authority inspections.

The scope of the role may include one or more cell therapy programs (clinical/commercial), encompassing the internal and external manufacturing and testing of cell banks, gene delivery materials, drug product intermediates, drug product, and finished labeled drug product. This role will partner with Analytical Sciences and Technology, Process and Analytical Development, Manufacturing Sciences and Technologies, Stability, Quality Assurance, Quality Control, GRS CMC to develop and execute product quality strategies. 

 

Key responsibilities: 

The Senior Director, Cell Therapy Global Product Quality Lead will lead a matrixed team of Product Quality Leaders to: 

Partner across Global Product Quality, Analytical Sciences and Technology, CT Development and Operations, and CT Regulatory CMC to define and deliver product quality strategies that comply with internal and external quality standards and regulatory requirements. 

Provide global product quality oversight of assigned areas of responsibility and support manufacturing operations including developing and maintaining relationships with partner organizations.  

Support the overall Quality plan based on Cell Therapy Development and Operations annual goals, critical projects, and/or life-cycle support for Product Team objectives, regulatory commitments, and process and product monitoring KPIs.  

Provide quality expertise in accordance with global regulatory requirements and internal policies in support of product characterization, product specifications, method validation, stability and comparability assessments for manufacturing and site changes.  

Drive timely and compliant completion of the Annual Product Quality Review ensuring coordination with leads of contributing. 

Perform Quality review of CMC sections of regulatory submissions and responses. May author CMC sections or responses to queries, as needed. 

Represent Quality in CMC meetings with global regulatory agencies and during regulatory inspections.  

Represent Quality on the CMC and GO-CT teams.  

Act as QA approver for product specifications and product labeling as needed. 

Provide supportive quality oversight and guidance during product launch to program teams. 

Provide strategic guidance and facilitate the timely implementation of manufacturing and testing changes.  May own 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. 

Influence industry and health authorities and ensure staff present at external conferences 

Identify and mentor future leaders 

Knowledge and Skills:  

The Sr. Dir. CT-GPQL, must be skilled in the development of quality strategies with little external guidance, ensuring product quality throughout the lifecycle. The Sr. Dir. CT-GPQL is a motivated, engaged, solutions-driven, strategic, and adaptable leader who supports the ED CTQ GPQ and the senior Cell Therapy Leadership Team, in the advancement of quality readiness. In particular, the Sr. Dir. CT-GPQL has: 

Expertise in GMP compliance, global regulations, and strong understanding of pharmaceutical product development lifecycle, with specific emphasis on gene delivery and cell therapy preferred.  

Experience authoring, reviewing, and representing Quality in support of both clinical and commercial regulatory submissions across multiple domestic and international jurisdictions.  

Demonstrated decision making and problem-solving capabilities relative to Quality, compliance, technical considerations, and regulatory requirements 

Demonstrated Quality leadership through partnership in a matrixed organization is required  

Working background in Biologics, Gene Delivery, or Cell Therapy Manufacturing 

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  

Experience implementing quality strategy and standards  

Direct experience participating in interactions with global regulatory agencies and in the preparation of regulatory submissions 

Demonstrated ability to develop technical and strategic leadership talent to meet current and future business needs 

Strategic thinker who sees the bigger picture and possesses high business acumen; understands how the parts impact the whole (end to end enterprise) and makes the best decisions for the whole 

Excellent influence and negotiation experience and capability in a matrix environment 

Able to interact with senior leaders from both Cell Therapy Development and Operations and GPS in this capacity and as such is seen as a highly regarded and a credible leader with the ability to act on behalf of the ED of CTQ to interface with stakeholders in a matrix environment 

The ability to anticipate and effectively influence future trends in the industry. 

 

Professional experience and qualifications: 

Master’s or PhD degree in Biochemistry, Immunology, Molecular Biology, Chemistry, Biology or corresponding engineering discipline preferred 

At least 12 years of experience in cell therapy, pharmaceutical and/or biotechnology fields in Manufacturing Operations or Quality roles 

Travel: This role requires about 10% travel. 

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: $238,270 - $288,730 Seattle - WA: $244,950 - $296,825 Summit West - NJ - US: $222,680 - $269,839

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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