Quality Director

Working with Us Challenging. Meaningful. Life-changing. Those aren’t words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual. Here, uniquely interesting work happens every day, in every department. From optimizing a production line to the latest breakthroughs in cell therapy, this is work that transforms the lives of patients, and the careers of those who do it. You’ll get the chance to grow and thrive through opportunities uncommon in scale and scope, alongside high-achieving teams. Take your career farther than you thought possible. 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. Read more: careers.bms.com/working-with-us. Job Function Ensure the commercial and investigational products manufactured and/or tested and released within the scope of the Manufacturing and Importation Authorisations (MIAs) for the manufacturing site comply with the registered quality specifications and the registration files in accordance with the expectations of Global Regulatory Health Authorities and BMS requirements. Responsibilities * Directing all aspects of site quality programs, systems, operations and compliance activities, including, Quality Assurance, Compliance and Quality Assurance Validation. * Ensuring appropriate GMP Quality Systems are in place and assuring a state of health authority inspection readiness. * Ensuring site GMP required procedures are in alignment and compliance with BMS Quality Management System (QMS) Process Framework. * Ensuring that deviations from procedures and specifications are investigated, resolved and documented. * Interfaces with Regulatory Agencies as necessary, leads site regulatory inspections and ensure compliance with the marketing authorization requirements. * Participating in the product recall and health authority notification process in accordance with BMS procedures. * Exercise sound judgment in making decisions and recommendations within generally defined practices and policies and notifies appropriate levels of management within Global Quality of significant quality issues immediately and develops strategy and directs resolution with a cross-functional team. * Ensures budget development and the preparation of periodic projections of spending against budgets; and manages and controls departmental spending. * Ensures quality and compliance oversight of regulatory submissions and new product introduced to the site. * Holds a key strategic position within the Biologics Operating Unit and is on the Site Leadership Team at Site and represents all areas of Global Quality as they pertain to operations at Site at the site Leadership Team. Required Competencies * Core competencies include leadership, communication skills, teamwork, problem-solving and a commitment to compliance and continuous improvement. * Proficient communicator (verbal, written and presentation skills) that has the ability to communicate effectively with all levels of management. * Ability to collaborate and build relationships cross functionally and influence internally/externally as appropriate, with proven track record of working in organizations with complex matrix structures. * Demonstrated success as a strong team leader who uses past supervisory experience to develop departmental staff through effective feedback and coaching. Required Qualification(s) and Desired Experience * Educated to a degree level in science, engineering or related discipline with a minimum of 15 years’ experience in a Quality Leadership Role in the pharmaceutical Industry. Master's degree preferred. * Must be able to understand and communicate effectively in the English language. * An in-depth knowledge of Japanese regulatory/GMP...