Associate Director Cell Therapy QA External Drug
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 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.
**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 time
**Duties 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 represen
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