Bristol Myers Squibb
Manager, Quality Assurance Technical Operations - Investigations
Bristol Myers Squibb, Devens, Massachusetts, United States, 01434
Manager, Quality Assurance Technical Operations - Investigations
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. Key responsibilities include: Provides quality support to Devens Site through quality review and approval of investigations. Reviews and approves discrepancy reporting, investigations and corrections and actions associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems. Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports. Provide guidance and decision making on deviation decisions within the manufacturing site and support areas. Perform routine GMP walkthroughs of processing and support areas within the Devens site. Perform routine GEMBA activities to support compliance and investigation triage/support. Quality support of Quality Control laboratories, Technical Services programs, clinical product technical transfers, and equipment maintenance activities. Participates as requested in the response team for audits and inspections by world health authorities. May provide guidance to less experienced staff. Drives opportunities for continuous improvement through project leadership and group engagement. Represents QA in cross-functional meetings. Provides training on QA-owned procedures. Qualifications and experience: Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred. A minimum of 6 years of relevant experience in a regulated environment with at least 4 years focused on product quality Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable. Extensive knowledge of US and EU cGMP regulations and guidance. Knowledge of Quality Risk Management principles preferred. Knowledge of electronic systems including any of the following: SAP, LIMS, Infinity, LES, Maximo, Vault and Syncade desirable. Experience working in a team-based environment with a diverse group of people. Excellent writing and oral communication skills are required. Ability to work extended hours or a modified work schedule is required for coverage of 24/7 manufacturing operations. The starting compensation for this job is a range from $97,440.00 USD to $126,900.00 USD 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 careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. 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. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. 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. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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. Key responsibilities include: Provides quality support to Devens Site through quality review and approval of investigations. Reviews and approves discrepancy reporting, investigations and corrections and actions associated with all areas of the manufacturing process including, incoming, manufacturing, facility, and utility systems. Provides quality support and oversight for Manufacturing Science and Technology and Validation protocols and reports. Provide guidance and decision making on deviation decisions within the manufacturing site and support areas. Perform routine GMP walkthroughs of processing and support areas within the Devens site. Perform routine GEMBA activities to support compliance and investigation triage/support. Quality support of Quality Control laboratories, Technical Services programs, clinical product technical transfers, and equipment maintenance activities. Participates as requested in the response team for audits and inspections by world health authorities. May provide guidance to less experienced staff. Drives opportunities for continuous improvement through project leadership and group engagement. Represents QA in cross-functional meetings. Provides training on QA-owned procedures. Qualifications and experience: Knowledge of science generally attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred. A minimum of 6 years of relevant experience in a regulated environment with at least 4 years focused on product quality Knowledge of biotech bulk and finished product manufacturing, analytical testing is highly desirable. Extensive knowledge of US and EU cGMP regulations and guidance. Knowledge of Quality Risk Management principles preferred. Knowledge of electronic systems including any of the following: SAP, LIMS, Infinity, LES, Maximo, Vault and Syncade desirable. Experience working in a team-based environment with a diverse group of people. Excellent writing and oral communication skills are required. Ability to work extended hours or a modified work schedule is required for coverage of 24/7 manufacturing operations. The starting compensation for this job is a range from $97,440.00 USD to $126,900.00 USD 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 careers.bms.com/life-at-bms/. Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Wellbeing support such as the BMS Living Life Better program and employee assistance programs (EAP). Financial well-being resources and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance, supplemental health insurance, business travel protection and survivor support. 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. Parental, caregiver, bereavement, and military leave. Family care services such as adoption and surrogacy reimbursement, fertility/infertility benefits, support for traveling mothers, and child, elder and pet care resources. Other perks like tuition reimbursement and a recognition program. BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. 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. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.