Specialist QA Cell Therapy

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. The position of Specialist QA, Cell Therapy will report administratively and functionally to the Associate Director, Quality Operations EU QP Cell Therapy with the primary role to provide support to the EU QP Operations – Cell Therapy team functions to ensure the smooth running of the department. The role will involve the co-ordination and control of the department’s documentation (including GMP documents), forecasts, planning, scheduling, and maintenance of the department’s management systems and databases. Skills/Knowledge Required Experience in Quality Assurance for Advanced Therapy Medicinal Products (ATMPs) is preferred. Strong knowledge in computer tools and software. Ability to work independently, yet effectively in a team-oriented environment. Strong sense of responsibility, reliability, accuracy, and timely work. Ability to handle multiple tasks and deadlines simultaneously. Good organizational skills. Good written and verbal communication skills in English. Sense of team spirit, initiative, service and sense of urgency. This individual must be highly motivated and enjoy working in a fast-paced, matrix environment. Able to interact cross-functionally and at different levels within BMS and with external partners. Because the department is relatively new and anticipating rapid growth, some flexibility with regards to responsibilities may be required. Duties and Responsibilities Collect and collate batch record documentation in preparation for QP certification of Cell Therapy products for the European market. Support the QP team organisationally in timely certification of Cell Therapy products for the European market. Write, update and review departmental procedures and work instructions. Archive relevant technical and GMP documentation for the department. Collect, record, analyse and report data on relevant departmental metrics. Provide support as required for regulatory audits/inspections (e.g. document preparation, scribing etc.). Maintain compliance with personal training requirements. 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.