Manager, Quality Engineering, Cell Therapy

Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms 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 rich in diversity. Take your career farther than you thought possible.

Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. We offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Position Summary

The Quality Engineering team is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer. The Digital Quality Manager, Quality Engineering is responsible for quality oversight of computer systems validation (CSV) activities.

Key Responsibilities

• Review and approve computer systems validation (CSV) lifecycle documentation associated with manufacturing site computerized and enterprise systems, including but not limited to system classification, user requirements, functional specifications, installation qualification, operational qualification / system testing, user acceptance testing, performance qualification, and periodic review.
• Owns and leads the administration and maintenance of the site technical review board and IT change management process, assuring consistency with establishing standards for local and global change control systems.
• Act as SME and/or Quality reviewer/approver for risk assessments, data integrity assessments, and technical reports supporting qualification.
• Perform routine quality review/approval activities associated with system onboarding and status.
• Perform periodic review of Digital systems.
• Review and approve commissioning and qualification lifecycle documentation associated with large, and/or complex or new projects, including but not limited to impact assessments, user requirements, configuration specifications, installation/operational qualification, performance qualification, and requalification activities.
• May represent Quality on large capital projects or technology transfer initiatives and review/approve validation plans.
• Identifies improvement opportunities and drives execution of team continuous improvement goals and projects.
• May review and approve or provide impact assessment for complex site change controls.
• Support internal and external inspections as required. Participate in the preparation and execution of corrective and preventative actions related to inspection findings.
• Maintain compliance with assigned learning plan. Support development of training content.
• Act as validation Subject Matter Expert and provide guidance/ coaching to less experienced staff with atypical events during qualification.
• Lead meetings and represent function at cross functional and network meetings. Share data/ knowledge within and across site and network. Build & maintain strong relationships with partner functions.

Qualifications & Experience

• Bachelor's degree in STEM field preferred or its equivalence.
• Over 6 years of experience in a regulated industry, including at least 3 years of experience in validation related experience. (CSV preferred, analytical equipment, equipment qualification). Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred.
• Demonstrated experience with electronic validation documentation systems.
• 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.
• Ability to interpret data & results, understand complex problems with multiple variables and critically assess and provide feedback on proposed solution and required documentation.
• Ability to critically review protocol reports, interpret results, and assess and challenge technical conclusions consistent with Quality risk management principles.
• Knowledge of manufacturing execution systems (MES) such as Syncade and distributive control such as Delta V is desirable.
• Knowledge of business systems such as SAP, LIMS, Maximo, Veeva Vault, and Valgenesis is desirable.
• Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex 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, with the ability to think critically to create innovative solutions.