Manager, Quality Engineering Cell Therapy

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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. Take your career farther than you thought possible.

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Manager, Quality Engineering Cell Therapy, Bristol-Myers Squibb Company, Devens, MA. Provide quality oversight on computer system lifecycle documents, commissioning and qualification lifecycle documents, risk assessments and strategies. Review and approve validation plan, qualification plan, data migration plan, data integrity risk assessment and Electronic Records & Electronic Signatures (ERES) Assessment in compliance with Food and Drug Act (FDA) regulations and company policies. Review and approve system risk assessment documents and ensure all mitigation strategies are developed and implemented for potential risks. Review and approve requirement specifications in validating new or modified processes, systems that supports manufacturing in the plant i.e., User Requirements Specification, Functional Specification, System configuration specification, Design specification, using extensive working knowledge of quality concepts and internal procedures. Support planning of validation testing activities and test strategy. Coordinate and execute the overall protocol process, including test case creation/pre-approval (installation /operational /performance qualification), test case post execution reviews/approval. Review and resolve protocol discrepancies associated with the qualification and startup of the Devens cell therapy facility and participate in resulting investigations and correction / corrective action planning. Release of systems for GMP use upon review/approval of system summary reports such as qualification protocol final reports, data migration reports, system validation report and requirement traceability matrix. Review and approve the periodic review reports to validated/qualified systems and assists with the identification of issues/trends and subsequent actions necessary to maintain the system's validated/qualified status. Support site deviation investigations and complete implementation of Corrective Action and Preventive Action (CAPA) actions. Responsible for maintenance of the site technical review board and IT change management process, assuring consistency with establishing standards for local and global change control systems. Ensure that all regulatory and cGMPs compliance items related to validation are satisfied and ensures validation master plan (VMP) adherence. Verify compliance with applicable BMS Policies, Guidelines and Directives and ensures consistency with other site procedures and/or specifications. Provide technical responses to audit inquiries and inspections from world health authorities on validation approach, protocols, validation master plans, project plans and Standard Operating Procedures (SOPs).

40 hrs/week, Mon-Fri, 8:30 a.m. - 5:30 p.m. $127,308 - $142,670/yr.    

MINIMUM REQUIREMENTS:

Master’s degree or foreign equivalent degree in Chemistry, Information Technology, Science or a related field, and four (4) years of post-baccalaureate work experience as a Validation Engineer, Quality Engineer, or related. In the alternative, the employer will accept a Bachelor’s degree or foreign equivalent degree in Chemistry, Information Technology, Science, or a related field plus six (6) years of post-baccalaureate experience as a Validation Engineer, Quality Engineer, or related.

Must have experience with/in:

• Regulatory requirements, including current Good Manufacturing practices (cGMP), Good practices (GxP), including 21CFR part 11, and Good Documentation practices (GDP);
• Life cycle documents, manufacturing methodologies/principles, cell therapy process;
• Application lifecycle management (ALM), electronic execution system and Quality Management systems (QMS);
• SAP