Bristol Myers Squibb · 2 days ago
Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens, MA
Devens, MA
Full-time
Onsite
Mid, Senior Level
$90K/yr - $109K/yr
4+ years expBristol Myers Squibb is a leading biopharmaceutical company focused on transforming patients' lives through science. The Senior Specialist, QA Investigations is responsible for quality oversight and approval of deviation investigations and associated action and effectiveness check records at the Devens Cell Therapy Facility, ensuring compliance with regulations and company policies.
BiotechnologyHealth CareMedicalPharmaceuticalPrecision Medicine
Responsibilities
Review and approve investigations/ CAPAs / effectiveness checks associated with the manufacturing site including but not limited to materials, manufacturing, laboratory, facility, and computer systems
May 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. Identifies improvement opportunities and supports execution of site/team continuous improvement goals and projects
Support internal and external inspections as required
Maintain compliance with assigned learning plan. Support development and delivery of training content to cross functional teams
Lead meetings and represent function at cross functional meetings. Share data/ knowledge within and across team. Build & maintain strong relationships with partner functions
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
4+ years of experience in a regulated industry with 1+ year deviation experience
Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred
Demonstrated experience with electronic system and databases
Demonstrated experience 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
Ability to interpret data & results, understand problems with few variables and critically assess and provide feedback on proposed CAPA
Ability 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 changing priorities
Detail oriented and task focused with ability to meet deadlines and support work prioritization
Able to work across functional groups and teams to ensure requirements are met
Self-motivated and contribute to a positive team environment
Confident in making decisions for minor issues and able to recognize Quality issues and 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
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
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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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