Senior Manager Cell Therapy QA External Drug Product Quality
vor 6 Monaten
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 rich in diversity. Take your career farther than you thought possible.
Just as Cell Therapy is redefining personalized medicine, BMS has a leading position in the industry defining Cell Therapy Patient Experience, for our patients, caregivers, providers and partners. BMS is the only company with two commercially approved CAR-T products and has one of the most promising pipelines to further drive success of Cell Terapy medicine. Our Cell Therapy organization’s mission is to define and deliver the world’s most trusted cell therapy experience and we are looking for an Individual to join us in this undertaking.
This professional will take a key function in our Cell Therapy manufacturing network. He/She will be responsible to independently manage the operational activities related to different external partners. This includes the oversight at the external sites as well as internal processes. The candidate will partner with various functions and sites in order to maintain flawless manufacturing operations. Furthermore this professional will closely partner with the assigned Quality leads for each external partner to drive projects and efficiency across End to End manufacturing.
Position Summary
Oversee and control operational tasks performed by external partners involved in Cell Therapy (CAR-T) manufacturing. Independently execute internal operational Quality tasks related to manufacturing steps for CAR T products in Europe. Partner with QA VPT Leads to provide Quality oversight of Contract Manufacturing Organizations (CMOs) Partner with VPT teams and acting as central point of contact for all Quality related topics in relation to the assigned tasks for internal and external stakeholders. Take lead in projects, escalations or other initiativesDuties/Responsibilities
Provide Quality oversight of Contract Manufacturing Organizations (CMOs) performing critical manufacturing steps for clinical CAR T products in Europe. Support early commercial launches if applicable. Partner with QA lead functions and/or deputizing in cross functional VPT team and acting as central point of contact for Quality related topics in relation to the assigned tasks for internal and external stakeholders. Responsible and accountable for- internal batch record review, QA release, disposition, and related qualification
- review and approval of CMO deviation investigations, CAPA and controlled documents (Master records)
- review and approval of internal investigations and CAPA affecting the CMO
- QA impact assessment and approval of CMO related changes.
- generation and review of Annual Product Quality Reviews (APQR) in collaboration with external partners and internal functions.
- generation and presentation of metrics, key performance indicators and respective dashboards Lead and prepare escalation meetings and related Quality records (Material review boards, Notification to management, Fact finding meetings) Prepare input for internal management reviews and deputize in presenting CMO related metrics, issues, and projects. Prepare and present input for Quality Review meetings with internal and external management. Represent BMS External Quality organization in internal inspections and audits for the assigned tasks. Support or take lead in Technology Transfer from internal sites to CMO and/or key projects related to manufacturing process like expansions, ramp up or major process changes. Ensure flawless execution of Transfer, Qualification and Validation of manufacturing process, devices, and analytical methods in collaboration with Project team and relevant Subject matter experts. Provide Quality oversight of routine operations at CMOs in support of cell therapy (CAR T) intermediate and final DP 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. Support in data auditing and review of protocol/reports and filing sections in support of regulatory submissions. Partner with stakeholders across different operational functions to define projects in order to continuously improve processes and performance. Partner and provide support to the Qualified Person (QP) with respect to finished drug product release for EU Own internal processes and procedures and drive continuous improvements.
Qualifications
Master’s degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas. Min. 7 years EU GMP regulated industry experience with a minimum of 5 years’ experience in quality assurance and/or compliance. Strong knowledge of relevant regulations and guidance for ATMP. Expertise in Transfer Projects and process changes (e.g. Tech Transfer, Analytical Method Transfer, Ramp up projects) Fluent in English, and preferably local language of CMO Strong organizational skills, including ability to follow assignments through to completion. 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 teams Proficient in communication with external partners to build a trustful and professional relationship Ability to prioritize and successfully manage complex and competing tasks and projects Travel: This position requires up to 20% of travel Uniquely Interesting Work, Life-changing Careers
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 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 Protocol
BMS has a diverse 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.
Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.
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