Senior Manager, Product Quality Cell Therapy

Bristol Myers Squibb • Devens, MA

9d • Hybrid

About The Position

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.

Requirements

• 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.

Nice To Haves

• 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.

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.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior