|Category||Qlty Assurance Methods||Job type||Full-Time|
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.
Celgene (a wholly owned subsidiary of Bristol-Myers Squibb) is a global biopharmaceutical company committed to changing the course of human health through bold pursuits in science, life-enhancing therapies, and a promise to always put patients first. At the core of that mission are the talented individuals who contribute their unique skill sets to help us drive innovation and deliver truly life-changing drugs for our patients. As we continue to pursue that mission, we're looking for talented professionals like you to join our team.
Prerequisites (As Applicable)
Remote position to support audits throughout Germany - up to 70%-80% travel required
Cell Therapy is at the epicenter of personalized medicine, and this exciting opportunity gives the candidate an opportunity to support the innovative and growing expansion of CAR-T therapies into European markets, for clinical and commercial purposes.
The Specialist will support this objective through the auditing of apheresis collection centers, the sites where a patient's blood is withdrawn, packaged, and shipped according to specified procedures. This is a critical role within the Global Compliance team that requires someone with demonstrated experience conducting audits in a regulated environment, familiarity with blood and tissue-related regulations such as ATMPs, JACIE, and/or familiarity with apheresis operations.
Additionally, the Specialist will be able to contribute towards an annual risk assessment exercise, proposing and implementing audit process improvements, developing quarterly and annual metrics, and may have the opportunity to cross-train to support GMP/GDP audits related to other CAR-T vendors such as material suppliers, manufacturing organizations, analytical labs, and more.
In this role, you will be responsible for (but not limited to):
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.