Manager, Quality Assurance Operations Car-t
vor 2 Wochen
At 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 every treatment we pioneer. Join us and make a difference.
Just as Cell Therapy is redefining personalized medicine, we are creating the industry defining Cell Therapy Operations, for our patients, caregivers, providers and partners. Our global Cell Therapy Development and Operations team’s mission is to define and deliver the world’s most trusted cell therapy manufacturing and distribution network and to install and maintain the highest quality standards.
**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
**Competences and Skills/Knowledge Required**:
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.
- 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 relationship
- Ability to prioritize and successfully manage complex and competing projects.
LI-Hybrid
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.
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