Manager, QA Operations Car-t
vor 5 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.
**The role**
Provide Quality oversight of Contract Manufacturing Organizations (CMOs) performing critical manufacturing steps for CAR T products in Europe.QA support in cross functional VPT team acting as point of contact for Quality related topics assigned in relation to the assigned CMO for internal and external stakeholders.
**Duties and Responsibilities**
- 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 disposition,
- 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 as well as collecting IA for changes raised by BMS.
- Support in data auditing and review of protocol/reports in support of regulatory submissions.
- Partner with stakeholders across different operational functions to define projects in order to continuously improve processes and performance.
- 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.
- Manage and delegate to direct reports as defined by the Senior Manager.
- Maintain Metrics related to Batch Disposition and Deviations.
- Lead improvement initiatives and projects as required.
- Responsible for Managing Change Controls raised and impact assessments and corresponding actions.
**Skills/Knowledge Required**
- Bachelor’s/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 4 years’ experience in quality assurance, quality control, and compliance.
- Expertise in Transfer Projects (e.g., Tech Transfer, Analytical Method Transfer).
- Strong 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 teams.
- Fluent in English, and preferably local language of CMO.
- Willingness to travel up to 50% of the time.
- Proficient in communication with external partners to build a trustful and professional relationships.
- Ability to prioritize and successfully manage complex and competing projects.
**Uniquely Interesting Work, Life-changing Careers**
**On-site Protocol**
Physical 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 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.
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