Senior Manager, Product Quality Cell Therapy

Bristol Myers Squibb

Seattle, WA

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JOB DETAILS

SALARY

$130,020–$157,559 Per Year

SKILLS

Analytical Development, Biotech and Pharmaceutical, Cell Biology, Change Management, Clinical Practices/Protocols, Clinical Trial, Collective Bargaining, Communication Skills, Consulting, Continuous Improvement, Cross-Functional, Data Analysis, Disability Accommodations, Document Change Management, Documentation, Drug Development, Editing, Field Sales, Follow Through, GMP (Good Manufacturing Practices), Healthcare Quality, Investigational New Drug (IND), Leadership, Maintain Compliance, Manufacturing, Manufacturing Operations, Matrix Management, Operations Management, Problem Solving Skills, Process Development, Process Manufacturing, Product Development, Product Documentation, Product Lifecycle, Product Reviews, Product Strategy, Product Support, Project/Program Coordination, Quality Assurance, Quality Control, Quality Management, Quality Metrics, Regulations, Regulatory Compliance, Regulatory Requirements, Regulatory Submissions, Reporting Skills, Risk Analysis, Sales Operations, Support Documentation, Team Player, Technical Support, Willing to Travel

LOCATION

Seattle, WA

POSTED

30+ days ago

**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 a **Senior Manager, Product Quality** within Global Product Quality to support **early- and late-stage clinical development projects** in the Cell Therapy Development Organization. This role will provide **product quality and GMP compliance support** for clinical-stage programs, contributing to successful program execution from early development through **late-stage clinical readiness and preparation for Biologics License Application (BLA) submission** . The **Senior Manager, Product Quality** will **support technical and quality oversight** of development programs, including vector, gene editing, and cell therapy projects, ensuring alignment with global GMP requirements, internal quality standards, and evolving regulatory expectations. The role supports quality activities across clinical phases, with increasing focus on **late-stage programs preparing for pivotal trials and BLA submission** , including quality readiness and documentation support. **Duties/Responsibilities** + **Provide product quality support and oversight** for assigned programs, including support of external manufacturing partners and internal manufacturing operations, through effective collaboration with site QA, QC, Analytical Development, Process Development, Manufacturing Sciences & Technology, and Regulatory Affairs. + **Support the execution of the overall product quality strategy** by aligning Quality activities with CMC / TCT deliverables, Product Development team objectives, lifecycle improvement initiatives, and regulatory commitments under the direction of senior Quality leadership. + **Provide technical quality and GMP compliance support** in accordance with global regulatory requirements and internal policies to enable clinical development activities and lifecycle management. + **Support the review of clinical and commercial regulatory filings** , including providing Quality input and assessments, with appropriate escalation and alignment with senior Quality and Regulatory stakeholders. + **Contribute to the development and maintenance of product quality guidance documents** and tools to support product quality requirements across the development continuum. + **Demonstrate effective influence and collaboration skills** , using clear communication and data-driven rationale to support alignment and adoption of quality solutions within cross-functional teams. + **Translate quality principles and regulatory expectations into actionable plans** , supporting implementation and execution to achieve program and compliance objectives. + **Coordinate Product Quality Team meetings** involving Site QA/QC, Analytical Development, Process Development, Manufacturing Sciences & Technology, Product Sciences, and Regulatory Affairs to ensure alignment, issue tracking, and follow-through. + **Prepare and coordinate program-specific materials and presentations** for forums such as the Product Quality Review Board, Product Specification Committee, and other cross-functional quality governance teams. + **Serve as a QA reviewer and approver** , as appropriate, for development reports, stability reports, and product specifications in alignment with role authorization and quality procedures. + **Support Quality oversight activities for early-stage programs** , including contributing to readiness for pivotal development through identification, assessment, and facilitation of required changes. + **Support the implementation of global changes** for assigned products by coordinating documentation, change activities, and stakeholder inputs in accordance with established change management processes. + **Contribute to continuous improvement initiatives and lifecycle management of GMP operations** , including supporting activities related to the transition from clinical to commercial phases. **Qualifications** + Education/Experience/Licenses/Certifications: Bachelor's or Master's degree in a relevant scientific or engineering discipline with 7-10+ years of experience in Quality within a biotechnology, pharmaceutical, or biopharmaceutical organization; experience supporting a Product Quality Leader (PQL) or similar Quality role is preferred. + Strong working knowledge of GMP compliance and global regulatory requirements, with a solid understanding of the pharmaceutical product development lifecycle, particularly in early to mid-stage development. + Experience supporting the review of regulatory submissions, including INDs, amendments, supplements, or related CMC documentation, under the guidance of senior Quality or Regulatory leaders. + Demonstrated technical capability with exposure to process development, analytical development, and/or data analysis, applied to support product quality and development activities. + Demonstrated sound judgment and problem-solving skills, with the ability to assess quality risks, propose solutions, and escalate issues appropriately in complex development environments. + Demonstrated ability to contribute to Quality leadership within a matrixed organization, partnering effectively with cross-functional teams while operating under established quality frameworks and governance. + Experience in Biologics or Cell Therapy manufacturing environments, including exposure to clinical-stage GMP operations and quality systems. + Proven ability to work cross-functionally and to develop effective working relationships with stakeholders across Quality, Manufacturing, Technical Development, and Regulatory functions. + Demonstrated leadership potential, including the ability to influence peers, communicate clearly, and support difficult discussions or decisions in collaboration with senior team members. + Ability to adapt and deliver in a dynamic regulatory and operational environment, managing competing priorities while maintaining compliance and quality standards. 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: $130,020 - $157,559 Madison - Giralda - NJ - US: $121,520 - $147,249 Seattle - WA: $133,660 - $161,968 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:** T he 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/ (https://careers.bms.com/eeo-accessibility) 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. R1601768 : Senior Manager, Product Quality Cell Therapy **Company:** Bristol-Myers Squibb **Req Number:** R1601768 **Updated:** 2026-05-23 01:35:16.028 UTC **Location:** Seattle 400 Dexter-WA Bristol Myers Squibb is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, protected veteran status, pregnancy, citizenship, marital status, gender expression, genetic information, political affiliation, or any other characteristic protected by law.

About the Company

Bristol Myers Squibb

INDUSTRY

Other/Not Classified

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