Bristol Myers Squibb
Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens, MA
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens, MA
Join our team as a Senior Specialist, Quality Assurance Investigations, Cell Therapy at Bristol Myers Squibb, located in Devens, MA. The role focuses on quality oversight, ensuring compliance with regulations and BMS policies at our Cell Therapy Facility.
About the Role The Senior Specialist, QA Investigations is responsible for quality oversight and approval of deviation investigations and associated action and effectiveness check records. This includes oversight of manufactured product quality, root cause analysis, and supporting continuous improvement initiatives.
Responsibilities
Review and approve investigations, CAPAs, and effectiveness checks for the manufacturing site, including materials, manufacturing, laboratory, facility, and computer systems.
Author, review, and approve technical reports such as risk assessments and deviation system monitoring reports to support the deviations program.
Ensure corrective/preventive actions are robust and adequately address the root cause.
Perform routine reporting and analysis of metrics to monitor timely closure of quality events and actions.
Identify improvement opportunities and support execution of site/team continuous improvement goals and projects.
Support internal and external inspections as required.
Maintain compliance with assigned learning plan and develop training content for cross‑functional teams.
Lead meetings and represent the function at cross‑functional meetings, sharing data and knowledge across teams.
Knowledge, Skills & Abilities
Ability to research, interpret, and apply internal policies and regulatory guidelines.
Proficient computer skills and familiarity with digital tools such as MS Office, Smartsheets, and new software applications.
Ability to interpret data, assess investigation results, and challenge technical conclusions consistent with quality risk management principles.
Excellent verbal and technical writing skills for preparing written communications and presenting data to management.
Comfortable working in a fast‑paced team environment with changing priorities.
Detail oriented with strong prioritization and deadline‑meeting skills.
Self‑motivated, collaborative, and capable of building relationships across functional groups.
Confident in making decisions for minor quality issues and solving problems.
Curious and capable of thinking critically to create innovative solutions.
Minimum Requirements
Bachelor’s degree in STEM field preferred; high‑school diploma/associate degree with equivalent work experience considered.
4+ years of experience in a regulated industry, with at least 1 year of deviation experience.
Experience in FDA/EMA regulations in biopharmaceutical or cell‑therapy manufacturing preferred.
Demonstrated experience with electronic systems and databases.
Proficient in root‑cause analysis tools such as 5‑WHY, human‑error prevention, Ishikawa diagram, and process flow diagram.
Compensation Base salary range: $89,780 – $108,789. Additional incentive cash and stock opportunities may be available based on eligibility.
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well‑being: 401(k) plan, disability insurance, life insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees: Unlimited paid time off with manager approval.
Phoenix, AZ, Puerto Rico, and Rayzebio Exempt/Non‑Exempt/Hourly Employees: 160 hours annual paid vacation, 11 national holidays, and 3 optional holidays.
Location Devens, MA
Seniority Level Associate
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About the Role The Senior Specialist, QA Investigations is responsible for quality oversight and approval of deviation investigations and associated action and effectiveness check records. This includes oversight of manufactured product quality, root cause analysis, and supporting continuous improvement initiatives.
Responsibilities
Review and approve investigations, CAPAs, and effectiveness checks for the manufacturing site, including materials, manufacturing, laboratory, facility, and computer systems.
Author, review, and approve technical reports such as risk assessments and deviation system monitoring reports to support the deviations program.
Ensure corrective/preventive actions are robust and adequately address the root cause.
Perform routine reporting and analysis of metrics to monitor timely closure of quality events and actions.
Identify improvement opportunities and support execution of site/team continuous improvement goals and projects.
Support internal and external inspections as required.
Maintain compliance with assigned learning plan and develop training content for cross‑functional teams.
Lead meetings and represent the function at cross‑functional meetings, sharing data and knowledge across teams.
Knowledge, Skills & Abilities
Ability to research, interpret, and apply internal policies and regulatory guidelines.
Proficient computer skills and familiarity with digital tools such as MS Office, Smartsheets, and new software applications.
Ability to interpret data, assess investigation results, and challenge technical conclusions consistent with quality risk management principles.
Excellent verbal and technical writing skills for preparing written communications and presenting data to management.
Comfortable working in a fast‑paced team environment with changing priorities.
Detail oriented with strong prioritization and deadline‑meeting skills.
Self‑motivated, collaborative, and capable of building relationships across functional groups.
Confident in making decisions for minor quality issues and solving problems.
Curious and capable of thinking critically to create innovative solutions.
Minimum Requirements
Bachelor’s degree in STEM field preferred; high‑school diploma/associate degree with equivalent work experience considered.
4+ years of experience in a regulated industry, with at least 1 year of deviation experience.
Experience in FDA/EMA regulations in biopharmaceutical or cell‑therapy manufacturing preferred.
Demonstrated experience with electronic systems and databases.
Proficient in root‑cause analysis tools such as 5‑WHY, human‑error prevention, Ishikawa diagram, and process flow diagram.
Compensation Base salary range: $89,780 – $108,789. Additional incentive cash and stock opportunities may be available based on eligibility.
Benefits
Health Coverage: Medical, pharmacy, dental, and vision care.
Well‑being Support: BMS Well‑Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well‑being: 401(k) plan, disability insurance, life insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off
US Exempt Employees: Unlimited paid time off with manager approval.
Phoenix, AZ, Puerto Rico, and Rayzebio Exempt/Non‑Exempt/Hourly Employees: 160 hours annual paid vacation, 11 national holidays, and 3 optional holidays.
Location Devens, MA
Seniority Level Associate
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