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 in Devens, MA
Working with Us: 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. The Senior Manager, QA Material Review Board role is responsible for the Material Review Board (MRB) process for non-conforming material at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. Responsibilities: Coordinate and prepare for Material Review Board (MRB) meetings by monitoring quality events and impact assessments. Review Pre-MRB Notification sent to Management and MRB Stakeholders, and draft as needed to support the MRB Coordinator. Oversee/Review coordination and compilation of Material Review Board (MRB) content for presentation to senior leadership, medical affairs, legal, and other program stakeholders. Chair MRB meetings and determining available treatment options for patients, leveraging cross functional analysis by stakeholders. Author as needed, and approve MRB Executive Summary with available treatment options and meeting minutes. Own and manage MRB outputs, action items, and Quality records. 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 solution and required documentation. Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy. 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+ year of quality system or lot disposition experience. Compensation Overview: Devens - MA - US: $130,020 - $157,559. Eligibility for specific benefits listed on our careers site may vary based on the job and location. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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Working with Us: 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. The Senior Manager, QA Material Review Board role is responsible for the Material Review Board (MRB) process for non-conforming material at the Devens, MA Cell Therapy manufacturing facility, in accordance with BMS policies, standards, procedures and Global cGMP. Responsibilities: Coordinate and prepare for Material Review Board (MRB) meetings by monitoring quality events and impact assessments. Review Pre-MRB Notification sent to Management and MRB Stakeholders, and draft as needed to support the MRB Coordinator. Oversee/Review coordination and compilation of Material Review Board (MRB) content for presentation to senior leadership, medical affairs, legal, and other program stakeholders. Chair MRB meetings and determining available treatment options for patients, leveraging cross functional analysis by stakeholders. Author as needed, and approve MRB Executive Summary with available treatment options and meeting minutes. Own and manage MRB outputs, action items, and Quality records. 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 solution and required documentation. Excellent verbal and technical writing skills with advanced ability to prepare written communications and present complex technical data to management with clarity and accuracy. 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+ year of quality system or lot disposition experience. Compensation Overview: Devens - MA - US: $130,020 - $157,559. Eligibility for specific benefits listed on our careers site may vary based on the job and location. BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.
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