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Operations Compliance Manager, External Cell Therapy Manufacturing

Company: Bristol Myers Squibb
Location: Seattle
Posted on: October 18, 2020

Job Description:

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. Position Summary: The Operations Compliance manager will be a member of External Manufacturing (EM) Project and Operations Management team. This individual will play a key role by managing compliance related activities such as Change Controls and deviations for Bristol Myers Squibb Cell Therapy Contract Manufacturing sites around the globe. In addition to this responsibility, we are looking for an individual who can support external manufacturing in other operational and project management functions. This role requires the ability to develop and maintain cooperative working relationships with team members to effectively close compliance related activities on time. Job Responsibilities: Lead and assist in compliance related activities originated by working with the Contract Manufacturing Organization (CMO). Initiate and manage Change Controls (CC) for EM and Strategic Sourcing Teams, ensure the CC are closely tracked till they are fully closed. Work closely with various groups and sites/ warehouses to provide support in resolving any operational issues. Initiate CMO notified deviations in Bristol Myers Squibb''s system. Follow up on CAPAs, work with team members, and QA to track and close them off. Work closely with QA team to close internal CC & Deviation impacting CMOs. Proactively identify operational risks and work with the team to develop contingency plans. Assist EM teams in other operational and project management functions as needed. Assist in preparation of monthly dashboards and tracking Key Performace Indicators (KPIs) for EM and Sourcing teams. Create and maintain reports that are utilized by EM and Sourcing team to drive decisions and advance projects. Leadership, Values and Behaviors: Deliver business results through timely and quality decision making Create an environment of teamwork, open communication, and sense of urgency Drive strong collaboration across the company and amongst external partners Build trust and effective relationships with peers, suppliers and stakeholders Foster a culture of high ethics and compliance Promote a mindset of continuous improvement, problem solving, and prevention Education: Bachelors Degree, preferably in Engineering or Science Requirements: 5-10 years of GMP manufacturing area, preferably bio-pharmaceutical Experience in Quality or technical writing function is a plus Experience working with compliance systems e.g. EQRM, Trackwise preferred Strong analytical, problem-solving, and critical thinking skills Project management skills is a plus Excellent organizational and time management skills Excellent verbal and written communication skills 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.by Jobble

Keywords: Bristol Myers Squibb, Seattle , Operations Compliance Manager, External Cell Therapy Manufacturing, Executive , Seattle, Washington

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