Position: Mid-Senior level

Job type: Full-time

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Job content

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.

Duties And Responsibilities
  • Provide Quality oversight of Contract Manufacturing Organizations (CMOs) performing critical manufacturing steps for CAR T products in Europe.
  • QA lead in cross functional VPT team acting as central point of contact for all Quality related topics in relation to the assigned CMO for internal and external stakeholders.
  • For new CMOs Partner with internal stakeholders in selection and onboarding of new CMOs. Take responsibility for Qualification of the selected partner.
  • Act as Quality lead in Technology Transfer from internal sites to CMO. 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 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
  • Build and lead a team of managers and specialists (if justified by volumes/workload) to manage the daily workload in accordance with given timelines. Support AD in budget planning and generation of head count models
  • 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
Competences/Skills/Knowledge Required
  • Bachelor’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, quality control, and compliance.
  • Willingness to travel up to 30% of the time
  • Advanced 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
Around the world, we are passionate about making an impact on the lives of patients with serious diseases. Empowered to apply our individual talents and diverse perspectives in an inclusive culture, our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues.

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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Deadline: 05-05-2024

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