Bristol Myers Squibb · 1 day ago
Associate Director, Principal Product Quality Lead
Devens, MA
Full-time
Onsite
Senior Level, Lead/Staff, Director/Executive
$174K/yr - $211K/yr
10+ years expBristol Myers Squibb is a leading biopharmaceutical company that is transforming patients' lives through science. They are seeking an Associate Director, Principal Product Quality Lead to oversee the lifecycle management of a commercial cell therapy product, ensuring regulatory compliance and providing technical expertise to various teams. The role involves global product quality oversight, compliance, and strategic guidance within the rapidly evolving cellular therapeutic field.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
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
Qualification
Required
BS/MS in relevant Science or Engineering discipline and 10+ years of experience in Quality in a biotech, pharmaceutical, or bio-pharmaceutical organization
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 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
Preferred
1-3 years of experience in a supportive PQL role is preferred
Demonstrated technical skillset with analytics and/or process development is preferred
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.
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
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.
Company
Bristol Myers Squibb
At Bristol Myers Squibb, we work every day to transform patients’ lives through science.
10001+ employees
H1B Sponsorship
Bristol Myers Squibb has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (247)
2024 (278)
2023 (231)
2022 (180)
2021 (181)
2020 (169)
Funding
Current Stage
Public CompanyTotal Funding
$29.32BKey Investors
Venrock
2025-11-05Post Ipo Debt· $5.74B
2024-02-14Post Ipo Debt· $13B
2023-10-30Post Ipo Debt· $4.5B
Leadership Team
Charles Bancroft
CFO
Cristian Massacesi
Executive Vice President, Chief Medical Officer and Head of Development
Recent News
2026-01-07
2026-01-07
2026-01-07
Company data provided by crunchbase