Senior Manager, QA Disposition Material Review Board in Devens, MA
Bristol-Myers Squibb
Senior Manager, QA Disposition Material Review Board in Devens, MA
Job Description
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. Scheduling MRB meetings and deliverables as needed. Oversee/Review coordination and compilation of Material Review Board (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. Coordinating, Co-authoring, and review of Integrated Health Hazard Assessment (IHHA) documents as needed. 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. 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 by assuring local compliance with applicable BMS Policies, Guidelines, and Directives and ensuring consistency with site and global procedures and/or specifications. Provide support, as needed, 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. Coaching and training new MRB coordinators. Support Disposition organization as needed. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities 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. and ability to learn and work with new software applications Advanced 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 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 Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered. 5+ years of experience in a regulated industry, preferably with 4+ year of quality system or lot disposition experience.
About the Role/Company
- Supporting People with Disabilities
Key Responsibilities
- Coordinate and prepare for Material Review Board (MRB) meetings by monitoring quality events and impact assessments
- Support the MRB Coordinator as needed for potentially non-conforming lots
- Review and draft Pre-MRB Notification sent to Management and MRB Stakeholders
- Schedule MRB meetings and deliverables as needed
- Oversee and review coordination and compilation of MRB content for presentation to senior leadership, medical affairs, legal, and other program stakeholders
- Coordinate, co-author, and review Integrated Health Hazard Assessment (IHHA) documents as needed
- Chair MRB meetings and determine available treatment options for patients
- Leverage cross-functional analysis by stakeholders to 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
- Assure local compliance with applicable BMS Policies, Guidelines, and Directives
- Ensure consistency with site and global procedures and/or specifications
- 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
Required Qualifications
- Bachelor's degree in STEM field preferred
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered
- + years of experience in a regulated industry
- + years of quality system or lot disposition experience
- Demonstrated experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
Preferred Qualifications
- Bachelor's degree in STEM field
Skills Required
- 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.
- Ability to learn and work with new software applications
- Advanced ability to interpret data & results, understand complex problems with multiple variables
- Critically assess and provide feedback on proposed solution 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
- 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 proficiency with electronic system and databases
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
130,000 - 190,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to research, understand, interpret and apply internal policies and regulatory guidelinesintermediate
- Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc.intermediate
- Ability to learn and work with new software applicationsintermediate
- Advanced ability to interpret data & results, understand complex problems with multiple variablesintermediate
- Critically assess and provide feedback on proposed solution and required documentationintermediate
- Ability to critically review investigation reports, interpret results, and assess and challenge technical conclusions consistent with Quality risk management principlesintermediate
- Excellent verbal and technical writing skillsintermediate
- Advanced ability to prepare written communications and present complex technical data to management with clarity and accuracyintermediate
- Ability to work in a fast-paced team environment and lead team and cross-functional stakeholders through changing prioritiesintermediate
- Ability to think strategically, meet deadlines and prioritize workintermediate
- Able to independently work across and influence cross-functional groups and network teams to ensure requirements are metintermediate
- Ability to motivate and foster a positive team environmentintermediate
- Confident in making decisions, able to anticipate Quality issues and proactively solve problemsintermediate
- Curious and ability to think critically to create innovative solutionsintermediate
- Experience working with protected health informationintermediate
- Demonstrated proficiency with electronic system and databasesintermediate
Required Qualifications
- Bachelor's degree in STEM field preferred (experience)
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered (experience)
- + years of experience in a regulated industry (experience)
- + years of quality system or lot disposition experience (experience)
- Demonstrated experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing (experience)
Preferred Qualifications
- Bachelor's degree in STEM field (experience)
Responsibilities
- Coordinate and prepare for Material Review Board (MRB) meetings by monitoring quality events and impact assessments
- Support the MRB Coordinator as needed for potentially non-conforming lots
- Review and draft Pre-MRB Notification sent to Management and MRB Stakeholders
- Schedule MRB meetings and deliverables as needed
- Oversee and review coordination and compilation of MRB content for presentation to senior leadership, medical affairs, legal, and other program stakeholders
- Coordinate, co-author, and review Integrated Health Hazard Assessment (IHHA) documents as needed
- Chair MRB meetings and determine available treatment options for patients
- Leverage cross-functional analysis by stakeholders to 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
- Assure local compliance with applicable BMS Policies, Guidelines, and Directives
- Ensure consistency with site and global procedures and/or specifications
- 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
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
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Senior Manager, QA Disposition Material Review Board in Devens, MA
Bristol-Myers Squibb
Senior Manager, QA Disposition Material Review Board in Devens, MA
Job Description
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. Scheduling MRB meetings and deliverables as needed. Oversee/Review coordination and compilation of Material Review Board (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. Coordinating, Co-authoring, and review of Integrated Health Hazard Assessment (IHHA) documents as needed. 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. 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 by assuring local compliance with applicable BMS Policies, Guidelines, and Directives and ensuring consistency with site and global procedures and/or specifications. Provide support, as needed, 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. Coaching and training new MRB coordinators. Support Disposition organization as needed. Work-life programs include paid national holidays and optional holidays, Global Shutdown Days between Christmas and New Year's holiday, up to 120 hours of paid vacation, up to two (2) paid days to volunteer, sick time off, and summer hours flexibility. Supporting People with Disabilities 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. and ability to learn and work with new software applications Advanced 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 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 Bachelor's degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered. 5+ years of experience in a regulated industry, preferably with 4+ year of quality system or lot disposition experience.
About the Role/Company
- Supporting People with Disabilities
Key Responsibilities
- Coordinate and prepare for Material Review Board (MRB) meetings by monitoring quality events and impact assessments
- Support the MRB Coordinator as needed for potentially non-conforming lots
- Review and draft Pre-MRB Notification sent to Management and MRB Stakeholders
- Schedule MRB meetings and deliverables as needed
- Oversee and review coordination and compilation of MRB content for presentation to senior leadership, medical affairs, legal, and other program stakeholders
- Coordinate, co-author, and review Integrated Health Hazard Assessment (IHHA) documents as needed
- Chair MRB meetings and determine available treatment options for patients
- Leverage cross-functional analysis by stakeholders to 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
- Assure local compliance with applicable BMS Policies, Guidelines, and Directives
- Ensure consistency with site and global procedures and/or specifications
- 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
Required Qualifications
- Bachelor's degree in STEM field preferred
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered
- + years of experience in a regulated industry
- + years of quality system or lot disposition experience
- Demonstrated experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
Preferred Qualifications
- Bachelor's degree in STEM field
Skills Required
- 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.
- Ability to learn and work with new software applications
- Advanced ability to interpret data & results, understand complex problems with multiple variables
- Critically assess and provide feedback on proposed solution 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
- 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 proficiency with electronic system and databases
Benefits & Perks
- Paid national holidays and optional holidays
- Global Shutdown Days between Christmas and New Year's holiday
- Up to 120 hours of paid vacation
- Up to two (2) paid days to volunteer
- Sick time off
- Summer hours flexibility
Locations
- Devens MA, United States
Salary
Estimated Salary Rangemedium confidence
130,000 - 190,000 USD / yearly
Source: ai estimated
* This is an estimated range based on market data and may vary based on experience and qualifications.
Skills Required
- Ability to research, understand, interpret and apply internal policies and regulatory guidelinesintermediate
- Proficient computer skills with knowledge of several digital tools like MS Office, Smartsheets etc.intermediate
- Ability to learn and work with new software applicationsintermediate
- Advanced ability to interpret data & results, understand complex problems with multiple variablesintermediate
- Critically assess and provide feedback on proposed solution and required documentationintermediate
- Ability to critically review investigation reports, interpret results, and assess and challenge technical conclusions consistent with Quality risk management principlesintermediate
- Excellent verbal and technical writing skillsintermediate
- Advanced ability to prepare written communications and present complex technical data to management with clarity and accuracyintermediate
- Ability to work in a fast-paced team environment and lead team and cross-functional stakeholders through changing prioritiesintermediate
- Ability to think strategically, meet deadlines and prioritize workintermediate
- Able to independently work across and influence cross-functional groups and network teams to ensure requirements are metintermediate
- Ability to motivate and foster a positive team environmentintermediate
- Confident in making decisions, able to anticipate Quality issues and proactively solve problemsintermediate
- Curious and ability to think critically to create innovative solutionsintermediate
- Experience working with protected health informationintermediate
- Demonstrated proficiency with electronic system and databasesintermediate
Required Qualifications
- Bachelor's degree in STEM field preferred (experience)
- High school diploma/Associates degree with equivalent combination of education and work experience may be considered (experience)
- + years of experience in a regulated industry (experience)
- + years of quality system or lot disposition experience (experience)
- Demonstrated experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing (experience)
Preferred Qualifications
- Bachelor's degree in STEM field (experience)
Responsibilities
- Coordinate and prepare for Material Review Board (MRB) meetings by monitoring quality events and impact assessments
- Support the MRB Coordinator as needed for potentially non-conforming lots
- Review and draft Pre-MRB Notification sent to Management and MRB Stakeholders
- Schedule MRB meetings and deliverables as needed
- Oversee and review coordination and compilation of MRB content for presentation to senior leadership, medical affairs, legal, and other program stakeholders
- Coordinate, co-author, and review Integrated Health Hazard Assessment (IHHA) documents as needed
- Chair MRB meetings and determine available treatment options for patients
- Leverage cross-functional analysis by stakeholders to 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
- Assure local compliance with applicable BMS Policies, Guidelines, and Directives
- Ensure consistency with site and global procedures and/or specifications
- 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
Benefits
- general: Paid national holidays and optional holidays
- general: Global Shutdown Days between Christmas and New Year's holiday
- general: Up to 120 hours of paid vacation
- general: Up to two (2) paid days to volunteer
- general: Sick time off
- general: Summer hours flexibility
Tags & Categories
Answer 10 quick questions to check your fit for Senior Manager, QA Disposition Material Review Board in Devens, MA @ Bristol-Myers Squibb.
10 Questions
~2 Minutes
Instant Score
Related Books and Jobs