Bristol Myers Squibb
Senior Manager, Quality Engineering in Devens, MA
Bristol Myers Squibb, Devens, Massachusetts, United States, 01434
Senior Manager, Quality Engineer
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. 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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. 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. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Senior Manager, Quality Engineer is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer. The Senior Manager, Quality Engineering is responsible for quality oversight. Responsibilities: Act as project lead for QA validation / engineering oversight. Managing deliverable timelines, and business process improvements. QE lead of the review, approval, and quality decision making for commissioning and qualification lifecycle documentation associated with large and/or complex facility, equipment, or utility projects. QE lead of the review, approval, and quality decision making for computer systems validation lifecycle documentation associated with manufacturing site digital systems. QE lead of the review, approval, and quality decision making for process validation lifecycle documentation associated with manufacturing site processes. Act as SME and/or Quality reviewer/approver for complex risk assessments, data integrity assessments, and technical reports supporting the manufacturing process and supporting systems. May perform routine quality review/approval activities associated with equipment/system onboarding and status. Represent Quality on large capital projects or technology transfer initiatives and review/approve complex validation or master transfer plans. Identifies improvement opportunities and drives execution of site/cross-functional continuous improvement goals and projects. May review and approve or provide impact assessment for complex site and global change controls. Support internal and external inspections as required. Participate in the preparation and execution corrective and preventative actions related to inspection findings. Maintain compliance with assigned learning plan. Support development of training content. Act as validation Subject Matter Expert in multiple validation disciplines and provide guidance/coaching to less experienced staff and cross-functional partners with atypical events during qualification. Lead meetings and represent function at cross functional and network meetings. Share data/knowledge within and across site and network. Build & maintain strong relationships with partner functions and global counterparts. Influence network teams on site behalf. 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, 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. Advanced 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 peers through changing priorities. Ability to think strategically, meet deadlines and support work prioritization for team. Able to independently work across and influence cross-functional groups and teams to ensure requirements are met. Ability to motivate and foster a positive cross-functional team environment. Confident in making decisions, able to anticipate Quality issues and proactively solve critical and/or complex problems. Curious, with the ability to think critically to create innovative solutions. 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 [insert validation discipline] experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Demonstrated proficiency with electronic validation documentation systems. The starting compensation for this job is a range from $130,700 - $158,400, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit.
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. 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. Bristol Myers Squibb recognizes the importance of balance and flexibility in our work environment. 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. At Bristol Myers Squibb we are reimagining the future of cell therapy. With our bold ambition, backed by a best-in-the-industry team and long-term commitment, we are leading the way to unlock the full promise of cell therapy as we strive to put more patients on the path to a cure. If you are ready to challenge yourself, accelerate your career, and give new hope to patients, there's no better place than here at BMS with our Cell Therapy team. The Senior Manager, Quality Engineer is responsible for quality oversight of engineering and validation lifecycle activities, including facility, equipment, and utility commissioning and qualification, computer systems validation, process validation, and technology transfer. The Senior Manager, Quality Engineering is responsible for quality oversight. Responsibilities: Act as project lead for QA validation / engineering oversight. Managing deliverable timelines, and business process improvements. QE lead of the review, approval, and quality decision making for commissioning and qualification lifecycle documentation associated with large and/or complex facility, equipment, or utility projects. QE lead of the review, approval, and quality decision making for computer systems validation lifecycle documentation associated with manufacturing site digital systems. QE lead of the review, approval, and quality decision making for process validation lifecycle documentation associated with manufacturing site processes. Act as SME and/or Quality reviewer/approver for complex risk assessments, data integrity assessments, and technical reports supporting the manufacturing process and supporting systems. May perform routine quality review/approval activities associated with equipment/system onboarding and status. Represent Quality on large capital projects or technology transfer initiatives and review/approve complex validation or master transfer plans. Identifies improvement opportunities and drives execution of site/cross-functional continuous improvement goals and projects. May review and approve or provide impact assessment for complex site and global change controls. Support internal and external inspections as required. Participate in the preparation and execution corrective and preventative actions related to inspection findings. Maintain compliance with assigned learning plan. Support development of training content. Act as validation Subject Matter Expert in multiple validation disciplines and provide guidance/coaching to less experienced staff and cross-functional partners with atypical events during qualification. Lead meetings and represent function at cross functional and network meetings. Share data/knowledge within and across site and network. Build & maintain strong relationships with partner functions and global counterparts. Influence network teams on site behalf. 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, 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. Advanced 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 peers through changing priorities. Ability to think strategically, meet deadlines and support work prioritization for team. Able to independently work across and influence cross-functional groups and teams to ensure requirements are met. Ability to motivate and foster a positive cross-functional team environment. Confident in making decisions, able to anticipate Quality issues and proactively solve critical and/or complex problems. Curious, with the ability to think critically to create innovative solutions. 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 [insert validation discipline] experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred. Demonstrated proficiency with electronic validation documentation systems. The starting compensation for this job is a range from $130,700 - $158,400, plus incentive cash and stock opportunities (based on eligibility). The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed. Final, individual compensation will be decided based on demonstrated experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits, please visit.