Associate Director Cell Therapy QA External Drug Product Quality
vor 7 Stunden
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 Therapy medicine. Our Cell Therapy organization’s mission is to define and deliver the world’s most trusted cell therapy experience, and this position will provide business process management services consistent with our Cell Therapy end-to-end Patient Experience mission.
This professional will take a key function in our Cell Therapy manufacturing network. He/She will act as Quality lead in a cross functional team (Virtual Plant Team) overseeing one of our high volume commercial Intermediate manufacturers in Europe. The candidate will partner with various technical and business functions to ensure flawless manufacturing and release of our products as well as driving future ramp up and improvement initiatives to further strengthen our commitment to help as many patients as possible.
Competences/Skills/Knowledge Required
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/or compliance. Strong knowledge of relevant regulations and guidance for ATMP. Expertise in Transfer Projects (e.g. Tech Transfer, Analytical Method Transfer) 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 projects Experienced in functional leadership and staff development. Willingness to travel up to 25% of the timeDuties and Responsibilities
Provide Quality oversight of Contract Manufacturing Organizations (CMOs) performing critical manufacturing steps for commercial and clinical CAR T products in Europe. Take responsibility of QA lead function in cross functional VPT team and acting as central point of contact for all Quality related topics in relation to the assigned CMO for internal and external stakeholders. Represent the organization in internal management reviews and take accountability for CMO related metrics, issues, and projects. Responsible for Quality Review meetings with internal and external management. If applicable represent BMS External Quality organization in internal inspections and audits. Act as Quality 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. Install and establish an operating model for management of the CMO with focus on Quality topics and support associate function in overall management. 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 and accountable for: - internal batch record review, QA release, disposition and/or respective qualification process - 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 Partner with global QA external manufacturing organization to manage the daily workload in accordance with given timelines as well as distribution of workload. Act as functional lead for the operative team members and take responsibility escalation process. Support management in budget planning and generation of head count models. 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. Delegate project representation to operational team members if applicable. Define and generate 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 EU 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.
-
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Director, Ww Medical Cell Therapy, Lymphoma
Vor 3 Tagen
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Associate Director, Cell Therapy Procurement
Vor 2 Tagen
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Associate Director, Operations Portfolio Lead
vor 1 Woche
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
QA Senior Specialist
Vor 2 Tagen
Boudry, Schweiz ALBEDIS VollzeitINTRODUCTION: For a major pharmaceutical company in the Neuchâtel area, we are looking for a 12-month temporary contract for two positions as : QA Senior Specialist / External Manufactoring H/F English - French & German a+ DESCRIPTION DE LA MISSION: As a QA Specialist, your main responsibilities will include: Vendor Quality Management : Overseeing...
-
QA Senior Specialist
vor 1 Tag
Boudry, Schweiz ALBEDIS VollzeitINTRODUCTION: For a major pharmaceutical company in the Neuchâtel area, we are looking for a 12-month temporary contract for two positions as : QA Senior Specialist / External Manufactoring H/F English - French & German a+ DESCRIPTION DE LA MISSION: As a QA Specialist, your main responsibilities will include: Vendor Quality Management : Overseeing...
-
QA Senior Specialist
Vor 2 Tagen
Boudry, Schweiz ALBEDIS VollzeitINTRODUCTION:For a major pharmaceutical company in the Neuchâtel area, we are looking for a 12-month temporary contract for two positions as :QA Senior Specialist / External Manufacturing H/FEnglish - French & German a+DESCRIPTION DE LA MISSION:As a QA Specialist, your main responsibilities will include:Vendor Quality Management :Overseeing contractor...
-
Manager, Quality Assurance Operations Car-t
Vor 7 Tagen
Boudry, Schweiz Bristol Myers Squibb VollzeitAt Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to...
-
Director, Quality Operations
Vor 2 Tagen
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Associate Director, Quality Services/compliance
vor 1 Woche
Boudry, Schweiz Bristol Myers Squibb VollzeitAt Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to...
-
Manager, Cell Therapy Logistics
Vor 7 Tagen
Boudry, Schweiz Bristol-Myers Squibb VollzeitManager, Cell Therapy Logistics & Warehousing - EMEA & APAC Manager, Cell Therapy Logistics & Warehousing - EMEA & APAC Apply locations Boudry - CH time type Full time posted on Posted 2 Days Ago job requisition id R1588193 Working with UsChallenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at...
-
Boudry, Schweiz Bristol Myers Squibb VollzeitAt Bristol Myers Squibb, we are inspired by a single vision - transforming patients’ lives through science. In oncology, hematology, immunology and cardiovascular disease - and one of the most diverse and promising pipelines in the industry - each of our passionate colleagues contribute to innovations that drive meaningful change. We bring a human touch to...
-
Clinical Quality
Vor 7 Tagen
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
-
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Market Access/heor Gbds Associate Director
vor 22 Stunden
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Associate Director Biostatistics
vor 1 Woche
Boudry, Schweiz Proclinical VollzeitProclinical are recruiting an Associate Director Biostatistics for a pharmaceutical organisation. This role is on a permanent basis. The client is focused on to aid patients overcome serious illnesses by finding, evolving and distributing novel treatments. **Responsibilities**: - Partake in planning the evolvement method that will enable an efficient and...
-
Clinical Quality
Vor 6 Tagen
Boudry, Schweiz Bristol Myers Squibb VollzeitBei Bristol Myers Squibb lassen wir uns von einer einzigen Vision inspirieren - die Veränderung des Lebens von Patienten durch Wissenschaft. In den Bereichen Onkologie, Hämatologie, Immunologie und Herz-Kreislauf-Erkrankungen - und eine der vielfältigsten und vielversprechendsten Pipelines der Branche - trägt jeder unserer leidenschaftlichen Kollegen zu...
-
Manager, QA Operations
vor 22 Stunden
Boudry, Schweiz Bristol-Myers Squibb Vollzeit**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...
-
Manager, QA Operations
Vor 3 Tagen
Boudry, Schweiz Bristol-Myers Squibb VollzeitWorking 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...
-
Associate Director, Operations Portfolio Lead
vor 22 Stunden
Boudry, Schweiz Bristol Myers Squibb Vollzeit**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...
