Quality Director

Job description

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 requirements. BMS Values All personnel are expected to display the BMS Values, which move us toward our mission to discover, develop and deliver innovative medicines that help patients prevail over serious diseases: If you come across a role that intrigues you but doesn’t perfectly line up with your resume, we encourage you to apply anyway. You could be one step away from work that will transform your life and career. Uniquely Interesting Work, Life-changing Careers With a single vision as inspiring as “Transforming patients’ lives through science™ ”, every BMS employee plays an integral role in work that goes far beyond ordinary. Each of us is empowered to apply our individual talents and unique perspectives in a supportive culture, promoting global participation in clinical trials, while our shared values of passion, innovation, urgency, accountability, inclusion and integrity bring out the highest potential of each of our colleagues. On-site Protocol BMS has an occupancy structure that determines where an employee is required to conduct their work. This structure includes site-essential, site-by-design, field-based and remote-by-design jobs. The occupancy type that you are assigned is determined by the nature and responsibilities of your role: Site-essential roles require 100% of shifts onsite at your assigned facility. Site-by-design roles may be eligible for a hybrid work model with at least 50% onsite at your assigned facility. For these roles, onsite presence is considered an essential job function and is critical to collaboration, innovation, productivity, and a positive Company culture. For field-based and remote-by-design roles the ability to physically travel to visit customers, patients or business partners and to attend meetings on behalf of BMS as directed is an essential job function. Supporting People with Disabilities BMS is dedicated to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace accommodations/adjustments and ongoing support in their roles. Applicants can request a reasonable workplace accommodation/adjustment prior to accepting a job offer. If you require reasonable accommodations/adjustments in completing this application, or in any part of the recruitment process, direct your inquiries to adastaffingsupport@bms.com. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. Candidate Rights BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. If you live in or expect to work from Los Angeles County if hired for this position, please visit this page for important additional information: https://careers.bms.com/california-residents/ Data Protection We will never request payments, financial information, or social security numbers during our application or recruitment process. Learn more about protecting yourself at https://careers.bms.com/fraud-protection. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations. If you believe that the job posting is missing information required by local law or incorrect in any way, please contact BMS at TAEnablement@bms.com. Please provide the Job Title and Requisition number so we can review. Communications related to your application should not be sent to this email and you will not receive a response. Inquiries related to the status of your application should be directed to Chat with Ripley. R1603811 : Quality Director