QA Manager Distribution CAR-T

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.

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.

This key position will provide Quality oversight of our external European importation and storage hub for CAR-T products. This professional will take responsibility for keeping the highest quality standards for commercial products as well as for ongoing and future clinical studies. In addition, this role will partner and provide support to the Qualified Person (QP) with respect to drug product release, disposition and distribution in Europe. The candidate will also be the connection between EU based external partners (manufacturer, distribution center) and US based Celgene sites involved in the complex and fast-paced supply chain of cell therapy products.

Duties And Responsibilities

• Provide Quality oversight of warehouse and distribution hub involved in CAR-T Supply chain for Europe.
• QA lead in a cross functional team managing the assigned CSP (Contract Service Provider). Acting as central point of contact for all Quality related topics in relation to the assigned CSP for internal and external stakeholders.
• Establish, maintain and improve an operating model for management of the CSP with focus on Quality topics and support associate functions in overall management.
• Negotiate Quality agreement and take responsibility for life cycle management.
• Provide Quality oversight of routine operations at CSP in support of cell therapy (CAR T) drug product release and disposition. 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.
• Ensure certification status of CSP by regular batch record review and monitoring performance based on metrics.
• review and approval of CSP deviation investigations, CAPA, change control and controlled documents (Master records).
• review and approval of internal investigations, CAPA and change control affecting the CSP.
• Partner with EU-QP team to ensure in-time release of finished batches to European market.
• Support CTDO wide projects including improvement projects as well as other transfer projects. Represent the QA function in the respective projects.
• For new distribution hubs Partner with internal stakeholders in selection and on-boarding of new hubs. Take responsibility for Qualification of the selected partner. Act as Quality lead in Technology Transfer from internal sites to distribution hub. Ensure flawless execution of Transfer, Qualification and Validation of storage capacities in collaboration with Project team and relevant SMEs.
  

Competences/Skills/Knowledge Required

• Bachelor’s degree in biochemistry, biology, microbiology, chemistry, engineering, pharmacy or closely related areas.
• Min. 5 years EU GMP/GDP regulated industry experience with a minimum of 3 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; available to act as a resource for colleagues.
• Fluent in English, and preferably local language of CSP (German)
• 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
• Flexible and open to adapt to changes
  

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.