Senior Specialist, Quality Assurance Investigations - Devens, MA

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About the Company

Working at Bristol Myers Squibb is challenging, meaningful, and life-changing. Here, uniquely interesting work happens every day, transforming the lives of patients and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Bristol Myers Squibb recognizes the importance of balance and flexibility, offering a wide variety of competitive benefits, services, and programs to support employees in both their professional and personal lives.

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 at the Devens Cell Therapy Facility. This role provides Quality oversight and assurance of the quality of manufactured products, in compliance with all applicable regulations and BMS policies and guidelines.

Responsibilities

• Review and approve investigations, CAPAs, and effectiveness checks associated with the manufacturing site, including but not limited to materials, manufacturing, laboratory, facility, and computer systems.
• Author, review, and approve technical reports, including risk assessments and deviation system monitoring reports, to support the deviations program.
• Ensure corrective and preventive actions are robust and adequately address the root cause.
• Perform routine reporting and analysis of metrics to ensure 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.
• Support development and delivery of training content to cross-functional teams.
• Lead meetings and represent the function at cross-functional meetings.
• Share data and knowledge within and across teams.
• Build and maintain strong relationships with partner functions.

Requirements

• Bachelor’s degree in a STEM field preferred. High school diploma or Associate’s degree with an equivalent combination of education and work experience may be considered.
• 4+ years of experience in a regulated industry with 1+ year of deviation experience.
• Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated experience with electronic systems and databases.
• Demonstrated experience in root cause analysis tools, including but not limited to 5-WHY, Human Error Prevention, Ishikawa Diagram (Fishbone Analysis), and Process Flow Diagram.

Skills

• Ability to research, understand, interpret, and apply internal policies and regulatory guidelines.
• Proficient computer skills with knowledge of digital tools like MS Office, Smartsheets, and the ability to learn new software applications.
• Ability to interpret data and 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 the ability to prepare written communications and present technical data clearly and accurately.
• Ability to work in a fast-paced team environment with changing priorities.
• Detail-oriented and task-focused, with the ability to meet deadlines and support work prioritization.
• Able to work across functional groups and teams to ensure requirements are met.
• Self-motivated and able to contribute to a positive team environment.
• Confident in making decisions for minor issues and able to recognize Quality issues and solve problems.
• Curious with the ability to think critically and create innovative solutions.

Pay

Devens, MA – $89,780 - $108,789 starting compensation range for a full-time employee. Additional incentive cash and stock opportunities (based on eligibility) may be available. Final, individual compensation will be decided based on demonstrated experience.