Manager, Quality Assurance Shop Floor, Cell Therapy at Bristol Myers Squibb

Working with UsChallenging. 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: 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 theres no better place than here at BMS with our Cell Therapy team.The Quality Assurance Shop Floor (QASF) organization has responsibility for quality oversight and responsibility for advising and assuring quality operations at the Devens Cell Therapy Facility in accordance with Bristol Myers Squibb (BMS) policies standards procedures and Global current Good Manufacturing Practices (cGMPs).In the capacity of QA Shop Floor Support the Manager Shop Floor QA Cell Therapy shall be responsible for handling Quality Assurance Shop Floor internal compliance and documentation tasks routine communication to front line employees and metrics/monitoring for key QASF processes. The incumbent will be considered a local process owner for core QASF systems/processes including but not limited to Alarm Review Batch Record Review and the GMP Walkthrough Program. The incumbent will be the steward for standard operating procedures training and managing relationships with key stakeholders.They will be accountable to monitor and track process performance related to key Shop Floor quality assurance quality tasks and other operational tasks through data and analytics; to own review or approve Floor Quality GxP records including but not limited to procedures CAPAs change controls impact assessments documentation or deviations; and represent QASF at relevant governance forums. Additionally the incumbent shall flex to support ad-hoc deviation approval or batch record review as requested by management. Effective communication critical thinking and a thirst for knowledge are foundational skills for members of the Shop Floor Quality Assurance team to succeed.This position reports to the Associate Director Shop Floor Quality Assurance.This is an individual contributor role working Monday to Friday.Shifts Available:M - F Standard Working HoursResponsibilities:Accountable for the performance/delivery of the QASF quality organization including oversight of the QA on-the-floor systems and programs that enable the highest quality and the quickest delivery of QA cGMP tasks.Develop and implement and continuously improve standard procedures and training for team-members related to quality systems.Proactively identify and address quality risks and critical issues drive mitigations with the aid of Quality Assurance staff and cross-functional partners and escalate to senior management as needed.Lead and/or represent QA in leadership staff and tier meetings governance forums or on project teams.Act as a QASF subject matter expert on behalf of the facility during audits and inspections.Provide timely QASF support to site compliance activities such as Change Control impact assessments deviation impact assessments and development of corresponding CAPAs.Advanced ability to synthesis information from multiple sources interpret problems and effectively communicate to cross-functional management in a clear brief and accurate manner.Respond to complex/critical issues and build a consensus of understanding with subject-matter experts for product impact and justification to continue manufacturing.Serve as a subject matter expert supporting others to navigate the BMS quality management system including but not limited to deviation and CAPA action management interim production controls disposition decisions and batch record management.Provide leadership to ensure routine on-the-floor Quality oversight and to ensure collaborative triages of unexpected events within the Manufacturing Quality Labs and Supply Chain operational areas and systems.Have a comprehensive understanding of Cell Therapy processes to enable real-time decision-making.Champion a culture that embraces psychological and physical safety of employees in the work environment.Champion a culture of teamwork communication and continuous improvement focused on defining problem statements driving initial investigative efforts and actioning solutions to reduce recurrence.Review and interpret the technical conclusions of a record/investigation and provide constructive feedback.Independently approve deviation records within the quality management system consistent with quality risk management principles and in accordance with process knowledge.Spend time coaching and mentoring operators and QASF staff while on the manufacturing floor.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 articulate practical solutions.Excellent written and verbal skills and advanced ability to present technical data effectively based on target audience.Ability to work in a fast-paced team environment and lead peers through changing priorities.Ability to think strategically meet deadlines and support work prioritizationAbility to negotiate and influence to craft mutually beneficial solutionsAbility to motivate and foster a positive team environmentExhibit strong decision-making and ability to think creatively while maintaining compliance and qualityPioneering mindset and ability to create innovative solutions.Demonstrated experience working with GxP electronic systems such as Manufacturing Execution Systems (MES) for electronic batch records; Enterprise Resource Planning (ERP) such as SAP; laboratory information management systems; or Quality Management Systems such as TrackWise or Veeva.Experience with microbial controls lean or six-sigma improvements or as a technical/scientific process engineer in the biopharmaceutical industry preferred.Demonstrated experience with quality management systems.Demonstrated experience with electronic system and databases such as Manufacturing Execution systems (MES) Enterprise Resource Planning (ERP)Basic Requirements:Bachelors degree in STEM field preferred. High school diploma/ Associates degree with equivalent combination of education and work experience may be considered.6 years of relevant cGMP experience preferably with 2 year of QA shop floor experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is management experience is preferred.Working Conditions:PHYSICAL /MENTAL DEMANDS: Able to work near strong magnetic fields.Able to gown for ISO 8 and ISO 7 rooms (medical scrubs safety shoes safety glasses gloves etc.).BMSCART#LI-ONSITEGPS2025If 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.Compensation Overview:Devens - MA - US: $100480 - $121756
The starting compensation range(s) for this role are listed above for a full-time employee (FTE) basis. Additional incentive cash and stock opportunities (based on eligibility) may be available. The starting pay rate takes into account characteristics of the job such as required skills where the job is performed the employees work schedule job-related knowledge and experience. 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 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 Years 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.Uniquely Interesting Work Life-changing CareersWith 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.On-site ProtocolBMS 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.Required Experience:Manager Key Skills Quality Assurance,FDA Regulations,Food Industry,Food Safety Experience,ISO 9001,Quality Systems,Food Processing,Quality Control,Quality Management,QA/QC,Selenium,HACCP Employment Type : Full-Time Experience: years Vacancy: 1