Senior Manager exQA CAR-T

Working with UsChallenging. 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 rich in diversity. 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: careers.bms.com/working-with-us.The Senior Manager provides quality oversight of Contract Manufacturing Organizations (CMOs) performing critical manufacturing steps for CAR T products in Europe.QA lead in cross functional VPT team acting as central point of contact for all Quality related topics in relation to the assigned CMO for internal and external stakeholdersPrimary responsibilities:For new CMOs: Partner with internal stakeholders in selection and onboarding of new CMOs. Take responsibility for Qualification of the selected partner. Act as Quality lead in Technology Transfer from internal sites to CMO. Ensure flawless execution of Transfer, Qualification and Validation of manufacturing process, devices and analytical methods in collaboration with Project team and relevant SMEs. Install and establish an operating model for management of the CMO with focus on Quality topics and support associate function in overall management.Support in VPT (Virtual Plant Team) model and act as delegate for Quality VPT lead Negotiate Quality agreement and take responsibility for life cycle management.Provide Quality oversight of routine operations at CMOs in support of cell therapy (CAR T) intermediate product manufacturing. Partner with CMO Quality to provide oversight of manufacturing operations and ensure work is performed in accordance with approved regulatory submissions, technical agreements, and applicable regulatory requirements.Responsible for:internal batch record review, QA release and dispositionreview and approval of CMO deviation investigations, CAPA and controlled documents (Master records),review and approval of internal investigations and CAPA affecting the CMOQA impact assessment and approval of CMO related changesLeading a team from functional perspective (if justified by volumes/workload) to manage the daily workload in accordance with given timelines for operational work. Support for VPT Lead in data auditing and review of protocol/reports in support of regulatory submissionsPartner with stakeholders across different operational functions to define projects in order to continuously improve processes and performanceSupport in key performance indicators (KPI) and metrics for CMO related activities and internal performance to support resource management. Partner and provide support to the Qualified Person (QP) with respect to finished drug product release for EURequirements: Bachelor’s/Master’s degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas.Min. 10 years EU GMP regulated industry experience with a minimum of 5 years’ experience in quality assurance and compliance.Expertise in Transfer Projects (e.g. Tech Transfer, Analytical Method Transfer)Good organizational skills, including ability to follow assignments through to completion.Advanced knowledge of relevant regulations and guidance for ATMP.Independent decision-making capability and ability to think conceptually and understand impact of decisions.Excellent verbal and written communication skills. Ability to work in cross functional teamsFluent in English, and preferably local language of CMOWillingness to travel up to 20% of the timeProficient in communication with external partners to build a trustful and professional relationship Ability to prioritize and successfully manage complex and competing projectsIf you come across a role that intrigues you but doesn’t 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 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 an inclusive culture, promoting diversity 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 ProtocolPhysical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture.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 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.Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.