Manager, Quality Assurance Technical Operations - Investigations
Manager, Quality Assurance Technical Operations - Investigations
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Job Description
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Challenging. Meaningful. Life-changing. Those arent 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. Youll 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. Read more: Manager Quality Assurance Technical Operations - Investigations Key Responsibilities 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 & 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 position is Monday through Friday first shift regular shift Monday- Friday 8:00 am - 5:00 pm. Hybrid. 50% on site. This means 3 days on site 2 off site and the next week 3 days off site in 2 days on site. If you come across a role that intrigues you but does not perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career. The starting compensation for this jobis a range from $97440.00 USD to $126900.00 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 decidedbased on demonstratedexperience. Eligibility for specific benefits listed on our careers site may vary based on the job and location. For more on benefits please visit subject to the terms and conditions of the applicable plans then in effectand may include the following: Medical pharmacy dental and vision care. Wellbeing supportsuch asthe 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 -life programs include paid national holidays and optional holidays Global Shutdown Days between Christmas and New Years holiday up to 120 hours of paid vacation up to two (2) paid days to volunteer sick time off and summer hours 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. #BMSBL BMSBLDMA #LI-HYBRID GPS2025 If you come across a role that intrigues you but doesnt perfectly line up with your resume we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work Life-changing Careers On-site Protocol 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 . Visit 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: data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.Location: Devens MA
With a single vision as inspiring as Transforming patients lives through science every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture promoting global participation in clinical trials while our shared values of passion innovation urgency accountability inclusion and integrity bring out the highest potential of each of our colleagues.
Required Experience:
Manager
Employment Type
Full-Time
