Senior Director, Product Quality Engineering

Bristol Myers Squibb•Devens, MA

2d•$223,640 - $298,092

About The Position

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 of Cell Therapy Product Quality Engineering reports to the Executive Director of Cell Therapy Global Product Quality and serves as a key leader within the GCTQ organization. This role leads a global team of quality professionals dedicated to ensuring the highest standards of cGMP compliance, product quality, and regulatory readiness at BMS. The Senior Director is accouantable for global standardization and harmonization of product quality principles, processes, and governance across the cell therapy portfolio. Operating in a matrixed environment, this position partners with Global Product Quality Leads and functional leaders to ensure consistent application of GPQ standards, risk frameworks, and lifecycle strategies. The role drives the vision for platform-based quality approaches and ensures alignment with regulatory expectations and business objectives across clinical and commercial assets.

Requirements

BS, MS, or PhD in Life Sciences (Biology, Chemistry, Engineering) or related field with 12–15+ years of experience in GMP Quality, with 7+ years in people management, and 5+ years supporting cell therapy, gene therapy, or advanced biologics manufacturing.
Demonstrated experience leading global quality teams in a matrixed environment, with a track record of hiring, coaching, and developing technical talent.
Deep knowledge of cGMP compliance, regulatory requirements, and quality systems in cell and gene therapy manufacturing.
Strategic thinker with strong analytical, problem-solving, and decision-making skills.
Excellent written and verbal communication skills, with an ability to interact effectively at all levels of the organization and with external partners.
Experience supporting technical transfers, process qualification, comparability, and validation for new manufacturing technologies.
Ability to work in a fast-paced environment, balancing agility with robust compliance and quality oversight.
Experience driving continuous improvement and supporting business process digitization within quality operations.

Nice To Haves

Experience with autologous CAR T cell therapy, viral vector manufacturing, and quality control equipment/system automation.
Product Quality Leadership experience for cell or gene therapy/ Track record supporting product launches, BLA submissions, and regulatory interactions for advanced cell and gene therapies.
Combination of experience in quality assurance, quality control, and compliance for process development, MS&T, and external manufacturing.

Responsibilities

Define and implement a global harmonization roadmap for GPQ standards, processes, and tools across all sites and programs.
Lead a global matrix team of product quality experts, influencing without direct authority to achieve alignment across products.
Drive lifecycle platform strategies for Integrated Control Strategy (ICS), Stability, analytical lifecycle management, jurisdictional control and specification strategy.
Harmonize product quality risk assessment (PQRA) methodologies and robustness metrics across programs.
Ensure all harmonized processes meet global regulatory requirements and support inspection readiness.
Partner with CTTO, QA/QC, Regulatory, and Manufacturing Operations to embed harmonized standards into operational workflows.
Foster a culture of innovation, agility, collaboration, and inclusion within the quality team, while maintaining a strong compliance and quality mindset.
Establish and meet ambitious quality performance and compliance metrics in alignment with business and financial objectives.
Lead internal and external governance meetings, including steering committees and partner collaborations, to ensure alignment and proactive quality management.

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.
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.

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