Bristol Myers Squibb · 2 hours ago
Manager, Quality Assurance Investigations, Cell Therapy
Devens, MA
Full-time
Onsite
Mid, Senior Level
$100K/yr - $122K/yr
6+ years expBristol Myers Squibb is a leading biopharmaceutical company focused on transforming patients' lives through science. The Manager, QA Investigations is responsible for quality oversight and approval of Deviation investigations and associated records at the Devens Cell Therapy Facility, ensuring compliance with regulations and company policies.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Review and approve complex investigations/ CAPAs / effectiveness checks associated with all aspects of manufacturing process including incoming, manufacturing, laboratory, facility, and utility systems
Author, review, approve technical reports, including but not limited to risk assessments and deviation system monitoring reports, to support the deviations program
Ensure the corrective/ preventive actions are robust and adequately address the root cause
May perform routine reporting and analysis of metrics to ensure timely closure of quality events and actions
Drive deployment of effective deviation processes within representative site/function
Coach employees on aspects of investigations
Resolve investigational process or system issues
Ensure appropriate issues are cascaded to global team and liaise with global team on routine basis
Provide relevant monitoring of functional area deviation metrics
Champion for culture of quality within the deviation program
Proactively monitor metrics and take relevant actions (including work prioritization) to ensure that disposition timelines and other targets are met
Identifies improvement opportunities and drives execution of site/team continuous improvement goals and projects
Support internal and external inspections as required
May present individual topics during audits as needed
Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams
Support integration of newer team members
Acts as Subject Matter Expert of the root cause analysis and investigations process and provides guidance/ coaching to less experienced staff with atypical events during day-to-day operations
Lead meetings and represent function at cross functional and network meetings
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 experience in a regulated industry, preferably with 2+ year of deviation experience
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred
Demonstrated experience with electronic system and databases
Demonstrated proficiency in root cause analysis tools including but not limited to 5-WHY, Human error prevention, Ishikawa Diagram (Fishbone Analysis), Process Flow Diagram, etc
Ability to research, understand, interpret and apply internal policies and regulatory guidelines
Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc. and ability to learn and work with new software applications
Demonstrated experience to interpret complex data & results, understand significant problems with multiple variables and critically assess and provide feedback on proposed CAPA
Demonstrated experience to critically review investigation reports, interpret results and assess and challenge technical conclusions consistent with Quality risk management principles
Excellent verbal and technical writing skills with ability to prepare written communications and present technical data to management with clarity and accuracy
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
Able to independently work across functional groups and teams to ensure requirements are met
Ability to motivate and foster a positive team environment
Confident in making decisions, able to anticipate Quality issues and proactively solve problems
Curious and ability to think critically to create innovative solutions
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
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 (213)
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
2025-12-30
BioWorld Financial Watch
2025-12-29
2025-12-25
Company data provided by crunchbase