Bristol Myers Squibb · 2 months ago
Manager, Quality Assurance Shop Floor, Cell Therapy
Devens - MA - US
Full-time
Hybrid
Mid, Senior Level
$100K/yr - $122K/yr
6+ years expBristol Myers Squibb is a leading company in cell therapy, dedicated to transforming the lives of patients through innovative science. The Manager, Quality Assurance Shop Floor will oversee quality operations at the Devens Cell Therapy Facility, ensuring compliance with internal policies and regulatory standards while managing key quality assurance processes.
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
Advanced ability to synthesis information from multiple sources, interpret problems and effectively communicate to cross-functional management in a clear, brief, and accurate manner
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
Demonstrated experience with quality management systems
Demonstrated experience with electronic system and databases such as Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP)
Preferred
Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry preferred
Project management experience is preferred
Benefits
Medical, pharmacy, dental and vision care.
Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP).
Financial well-being resources and a 401(K).
Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support.
Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility.
Parental, caregiver, bereavement, and military leave.
Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources.
Other perks like tuition reimbursement and a recognition program.
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
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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
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