Bristol Myers Squibb · 2 days ago
Manager, Shop Floor Quality Assurance, Cell Therapy in Devens, MA
Devens, MA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $122K/yr
6+ years expBristol Myers Squibb is a leader in the field of cell therapy, dedicated to transforming the lives of patients through innovative science. The Manager, Shop Floor Quality Assurance, Cell Therapy will lead a team responsible for ensuring quality compliance and oversight in manufacturing and quality control operations at the Cell Therapy Facility.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
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
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 direction and timely guidance to QA shift-managers regarding the handling and resolution of cGMP events which may be a part of deviations, batch record exceptions, and other quality operational issues
Accountable for the performance/delivery of the QA field 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 standard-work for team-members that balances on-floor support for non-routine events, routine quality assurance work, and stretch/development project-work
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
Proactively identify and address quality risks and critical issues, drive mitigations with the aid of Field Quality Staff and cross-functional partners and escalate to senior management as needed
Lead walkthroughs with peers or QA team-members to identify and remediate operational or quality issues
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
Regularly spend time coaching and mentoring operators and Field QA specialists while on the manufacturing floor
Interview, hire, coach, motivate, and develop exceptional staff. Set performance objectives and development plans. Monitor performance progress and conduct performance reviews for all direct reports
Qualification
Required
Ability to lead an on-site quality operations teams working a 6am to 6pm shift on a rotating 2-3-2 Panama schedule
Demonstrated experience with quality management systems for handling of records such as change control, product complaints, deviations, investigations, and CAPA management
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
Ability to research, understand, interpret, and apply internal policies, cGMP, and quality principles
Establishment of strategic goals, departmental objectives, and motivating team to achieve operational tasks
Exhibits strong decision-making ability and analytical thinking while maintaining compliance and quality
Proactively finds solutions to quality and operational problems by creative thinking and innovative solutions
Proven ability to negotiate mutually beneficial solutions and resolve differing perspectives among stakeholders
Ability to understand complex problems with multiple datum/variables and articulate practical solutions
Excellent technical writing/verbal skills. Ability to effectively present technical data based on target audience
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
Ability to lead change in a fast-paced environment with limited information and/or time-constraints
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is required
Ability to work within pharmaceutical cleanroom environments
6+ years of relevant cGMP experience, preferably with 2+ year of QA shop floor experience
Preferred
Experience working in aseptic/sterile environments and/or in quality control operations focused on microbial controls and contamination mitigation strategies
Experience with microbial controls, lean or six-sigma improvements, or as a technical/scientific process engineer in the biopharmaceutical industry
Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered
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
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
MedCity News
2026-01-06
Dallas Morning News
2026-01-05
2025-12-30
Company data provided by crunchbase