Bristol Myers Squibb
Senior Manager, QA Disposition Material Review Board in Devens, MA
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Senior Manager, QA Disposition Material Review Board
Join Bristol Myers Squibb as a Senior Manager, QA Disposition Material Review Board in Devens, MA. This role is responsible for the Material Review Board (MRB) process for non-conforming material at the Devens, MA Cell Therapy manufacturing facility. The successful candidate will oversee atypical events, coordinate with stakeholders, and act as MRB Chair. They will also be responsible for ensuring accurate and timely MRB facilitation and follow-up, including material conversion, maintenance, and review of SOPs. Responsibilities: Coordinate and prepare for Material Review Board (MRB) meetings Review Pre-MRB Notification sent to Management and MRB Stakeholders Oversee/Review coordination and compilation of Material Review Board (MRB) content for presentation to senior leadership Chair MRB meetings and determine available treatment options for patients Author and approve MRB Executive Summary with available treatment options and meeting minutes Own and manage MRB outputs, action items, and Quality records Record and manage MRB action items and approve MRB Record actions in electronic system Own and manage MRB and material conversion business processes at the manufacturing site Provide support to the MRB Coordinator in execution of Material Conversion activities Drive improvement initiatives related to MRB and Material Conversion Act as subject matter expert and present MRB and Material Conversion program overviews during inspections and audits Coach and train new MRB coordinators Support Disposition organization as needed Knowledge and Skills: 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. Advanced ability to interpret data & results, understand complex problems with multiple variables, and critically assess and provide feedback on proposed solutions and required documentation 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 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 team and cross-functional stakeholders through changing priorities Ability to think strategically, meet deadlines, and prioritize work Able to independently work across and influence cross-functional groups and network 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 and ability to think critically to create innovative solutions Experience working with protected health information Demonstrated experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing Demonstrated proficiency with electronic system and databases Basic Requirements: Bachelor's degree in STEM field preferred. High school diploma/Associates degree with equivalent combination of education and work experience may be considered 8+ years of experience in a regulated industry, preferably with 4+ years of quality system or lot disposition experience 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. Read more at careers.bms.com/working-with-us. Bristol Myers Squibb is an equal opportunity employer and welcomes applications from diverse candidates.
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Join Bristol Myers Squibb as a Senior Manager, QA Disposition Material Review Board in Devens, MA. This role is responsible for the Material Review Board (MRB) process for non-conforming material at the Devens, MA Cell Therapy manufacturing facility. The successful candidate will oversee atypical events, coordinate with stakeholders, and act as MRB Chair. They will also be responsible for ensuring accurate and timely MRB facilitation and follow-up, including material conversion, maintenance, and review of SOPs. Responsibilities: Coordinate and prepare for Material Review Board (MRB) meetings Review Pre-MRB Notification sent to Management and MRB Stakeholders Oversee/Review coordination and compilation of Material Review Board (MRB) content for presentation to senior leadership Chair MRB meetings and determine available treatment options for patients Author and approve MRB Executive Summary with available treatment options and meeting minutes Own and manage MRB outputs, action items, and Quality records Record and manage MRB action items and approve MRB Record actions in electronic system Own and manage MRB and material conversion business processes at the manufacturing site Provide support to the MRB Coordinator in execution of Material Conversion activities Drive improvement initiatives related to MRB and Material Conversion Act as subject matter expert and present MRB and Material Conversion program overviews during inspections and audits Coach and train new MRB coordinators Support Disposition organization as needed Knowledge and Skills: 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. Advanced ability to interpret data & results, understand complex problems with multiple variables, and critically assess and provide feedback on proposed solutions and required documentation 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 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 team and cross-functional stakeholders through changing priorities Ability to think strategically, meet deadlines, and prioritize work Able to independently work across and influence cross-functional groups and network 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 and ability to think critically to create innovative solutions Experience working with protected health information Demonstrated experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing Demonstrated proficiency with electronic system and databases Basic Requirements: Bachelor's degree in STEM field preferred. High school diploma/Associates degree with equivalent combination of education and work experience may be considered 8+ years of experience in a regulated industry, preferably with 4+ years of quality system or lot disposition experience 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. Read more at careers.bms.com/working-with-us. Bristol Myers Squibb is an equal opportunity employer and welcomes applications from diverse candidates.
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