Bristol Myers Squibb · 1 day ago
Manager, Quality Assurance Shop Floor, Cell Therapy
Devens, MA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $122K/yr
6+ years expBristol Myers Squibb is a leading company in the pharmaceutical industry, focused on transforming patients' lives through science. They are seeking a Manager for Quality Assurance on the Shop Floor in Cell Therapy, responsible for overseeing quality operations and compliance at the Devens Cell Therapy Facility. The role involves managing quality assurance processes, developing standard procedures, and ensuring effective communication within the team and across functions.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Accountable for the performance/delivery of the QASF quality organization, including oversight of the QA on-the-floor systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks
Develop and implement, and continuously improve standard procedures and training for team-members related to quality systems
Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Quality Assurance staff and cross-functional partners and escalate to senior management as needed
Lead and/or represent QA in leadership, staff and tier meetings, governance forums or on project teams
Act as a QASF subject matter expert on behalf of the facility during audits and inspections
Provide timely QASF support to site compliance activities such as Change Control impact assessments, deviation impact assessments, and development of corresponding CAPAs
Advanced ability to synthesis information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner
Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing
Serve as a subject matter expert supporting others to navigate the BMS quality management system including but not limited to deviation and CAPA action management, interim production controls, disposition decisions, and batch record management
Provide leadership to ensure routine on-the-floor Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing, Quality Labs, and Supply Chain operational areas and systems
Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making
Champion a culture that embraces psychological and physical safety of employees in the work environment
Champion a culture of teamwork, communication, and continuous improvement focused on defining problem statements, driving initial investigative efforts, and actioning solutions to reduce recurrence
Review and interpret the technical conclusions of a record/investigation and provide constructive feedback
Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge
Spend time coaching and mentoring operators and QASF staff while on the manufacturing floor
Qualification
Required
Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered
6+ years of relevant cGMP experience, preferably with 2+ year of QA shop floor experience
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred
Ability to research, understand, interpret, and apply internal policies and regulatory guidelines
Proficient computer skills with knowledge of several digital tools like MS Office, etc., and ability to learn and work with new software applications
Advanced ability to interpret data & results, understand complex problems with multiple variables, and articulate practical solutions
Excellent written and verbal skills and advanced ability to present technical data effectively based on target audience
Ability to work in a fast-paced team environment and lead peers through changing priorities
Ability to think strategically, meet deadlines, and support work prioritization
Ability to negotiate and influence to craft mutually beneficial solutions
Ability to motivate and foster a positive team environment
Exhibit strong decision-making and ability to think creatively while maintaining compliance and quality
Pioneering mindset and ability to create innovative solutions
Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or Quality Management Systems such as TrackWise or Veeva
Preferred
Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry preferred
Demonstrated experience with quality management systems
Project management experience 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
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.
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
2026-01-09
2026-01-08
Company data provided by crunchbase