Bristol Myers Squibb
Senior Manager, QA Disposition Material Review Board in Devens, MA
Bristol Myers Squibb, Harvard, Massachusetts, us, 01451
Overview
Senior Manager, QA Disposition Material Review Board
in Devens, MA Role at
Bristol Myers Squibb . The Senior Manager, QA Material Review Board (MRB) role is responsible for the MRB process for non-conforming material at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. This position oversees atypical events to ensure appropriate management notifications occur per procedure and coordinates with stakeholders to gather supporting documentation for MRB to deliver Drug Product to patients. Primary stakeholders include QA Disposition, QA/QC/MST Investigations, Medical, Legal, senior site leadership, and other product level teams. The role acts as MRB Chair, ensures accurate and timely MRB facilitation and follow up, including material conversion, maintenance and review of SOPs, and serves as primary point of contact for MRB. Work scope includes commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens.
Responsibilities
Coordinate and prepare for Material Review Board (MRB) meetings by monitoring quality events and impact assessments, supporting the MRB Coordinator as needed, for potentially non-conforming lots.
Review Pre-MRB Notification sent to Management and MRB Stakeholders, and draft as needed to support the MRB Coordinator. Schedule MRB meetings and deliverables as needed.
Oversee/Review coordination and compilation of MRB content for presentation to senior leadership, medical affairs, legal, and other program stakeholders as it relates to potentially non-conforming lots during the manufacture or testing of Cell Therapy Drug Products.
Coordinate, co-author, and review Integrated Health Hazard Assessment (IHHA) documents as needed.
Chair MRB meetings and determine available treatment options for patients, leveraging cross-functional analysis by stakeholders.
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 the electronic system.
Own and manage MRB and material conversion business processes at the manufacturing site, ensuring local compliance with applicable BMS Policies, Guidelines, and Directives and consistency with site and global procedures and specifications.
Provide support to the MRB Coordinator in execution of Material Conversion activities and 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 and support the 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 MS Office, Smartsheets, and ability to learn new software applications.
Advanced ability to interpret data and results, understand complex problems with multiple variables, and critically assess 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 the ability to prepare written communications and present complex technical data to management with clarity.
Ability to work in a fast-paced team environment and lead cross-functional stakeholders through changing priorities.
Strategic thinking, ability to meet deadlines and prioritize work; ability to influence cross-functional groups to ensure requirements are met.
Ability to motivate and foster a positive team environment; confident in decision-making and proactive problem solving.
Experience working with protected health information; familiarity with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
Proficiency with electronic systems and databases.
Basic Requirements
Bachelor's degree in a STEM field preferred. High school diploma/Associate degree with equivalent combination of education and work experience may be considered.
8+ years of experience in a regulated industry, preferably with 4+ year of quality system or lot disposition experience.
Additional Information Compensation: Devens, MA — $130,020 - $157,559. The starting compensation range is for a full-time employee; additional incentive cash and stock opportunities may be available. Benefits, work-life programs and location-specific information are provided on the careers site and in the offer letter. On-site protocol and accommodations information are described by BMS policies.
Uniquely Interesting Work, Life-changing Careers: With Transforming patients' lives through science, every BMS employee plays an integral role in work that goes beyond ordinary. BMS emphasizes values of passion, innovation, urgency, accountability, inclusion and integrity.
Location and Focus Site: Devens, MA; Role includes responsibilities across commercial and clinical manufacturing for cell therapy products.
Important Notices BMS is an equal opportunity employer. Reasonable accommodations are available upon request. Covid-19 vaccination and booster status are managed per policy. All data handling complies with applicable privacy regulations.
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Senior Manager, QA Disposition Material Review Board
in Devens, MA Role at
Bristol Myers Squibb . The Senior Manager, QA Material Review Board (MRB) role is responsible for the MRB process for non-conforming material at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. This position oversees atypical events to ensure appropriate management notifications occur per procedure and coordinates with stakeholders to gather supporting documentation for MRB to deliver Drug Product to patients. Primary stakeholders include QA Disposition, QA/QC/MST Investigations, Medical, Legal, senior site leadership, and other product level teams. The role acts as MRB Chair, ensures accurate and timely MRB facilitation and follow up, including material conversion, maintenance and review of SOPs, and serves as primary point of contact for MRB. Work scope includes commercial manufacturing and clinical manufacturing for all cell therapy products manufactured in Devens.
Responsibilities
Coordinate and prepare for Material Review Board (MRB) meetings by monitoring quality events and impact assessments, supporting the MRB Coordinator as needed, for potentially non-conforming lots.
Review Pre-MRB Notification sent to Management and MRB Stakeholders, and draft as needed to support the MRB Coordinator. Schedule MRB meetings and deliverables as needed.
Oversee/Review coordination and compilation of MRB content for presentation to senior leadership, medical affairs, legal, and other program stakeholders as it relates to potentially non-conforming lots during the manufacture or testing of Cell Therapy Drug Products.
Coordinate, co-author, and review Integrated Health Hazard Assessment (IHHA) documents as needed.
Chair MRB meetings and determine available treatment options for patients, leveraging cross-functional analysis by stakeholders.
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 the electronic system.
Own and manage MRB and material conversion business processes at the manufacturing site, ensuring local compliance with applicable BMS Policies, Guidelines, and Directives and consistency with site and global procedures and specifications.
Provide support to the MRB Coordinator in execution of Material Conversion activities and 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 and support the 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 MS Office, Smartsheets, and ability to learn new software applications.
Advanced ability to interpret data and results, understand complex problems with multiple variables, and critically assess 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 the ability to prepare written communications and present complex technical data to management with clarity.
Ability to work in a fast-paced team environment and lead cross-functional stakeholders through changing priorities.
Strategic thinking, ability to meet deadlines and prioritize work; ability to influence cross-functional groups to ensure requirements are met.
Ability to motivate and foster a positive team environment; confident in decision-making and proactive problem solving.
Experience working with protected health information; familiarity with FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing.
Proficiency with electronic systems and databases.
Basic Requirements
Bachelor's degree in a STEM field preferred. High school diploma/Associate degree with equivalent combination of education and work experience may be considered.
8+ years of experience in a regulated industry, preferably with 4+ year of quality system or lot disposition experience.
Additional Information Compensation: Devens, MA — $130,020 - $157,559. The starting compensation range is for a full-time employee; additional incentive cash and stock opportunities may be available. Benefits, work-life programs and location-specific information are provided on the careers site and in the offer letter. On-site protocol and accommodations information are described by BMS policies.
Uniquely Interesting Work, Life-changing Careers: With Transforming patients' lives through science, every BMS employee plays an integral role in work that goes beyond ordinary. BMS emphasizes values of passion, innovation, urgency, accountability, inclusion and integrity.
Location and Focus Site: Devens, MA; Role includes responsibilities across commercial and clinical manufacturing for cell therapy products.
Important Notices BMS is an equal opportunity employer. Reasonable accommodations are available upon request. Covid-19 vaccination and booster status are managed per policy. All data handling complies with applicable privacy regulations.
#J-18808-Ljbffr