Director, Quality Control

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. Position summary The Director QC is responsible for QC laboratory operations to ensure timely completion of testing (e.g., drug product, intermediates stability, raw materials and microbiology/EM) that is performed in compliance with regulatory agencies, cGMPs, and other company policies and procedures. Responsible for managing the QC budget. The Director QC is also responsible for on time closure of Lab investigations and associated CAPA’s. Oversee management and scheduling of multiple teams with varying functions and goals within the department. Responsibilities Directs QC laboratory to ensure timely completion of testing (e.g., drug product, intermediates, stability, raw materials) that is performed in compliance with regulatory agencies, cGMPs, and other company policies and procedures. Defines departmental roles and accountabilities. Hires, integrates, and develops high quality talent capable of delivering against the department’s goals and objectives. Establishes and communicates performance objectives for QC staff that are consistent with the business unit and Quality goals. Defines and monitors performance measures, provide developmental feedback and coaching, and creates a collaborative environment that attracts, develops, and retains the best talent. Accountable for lifecycle management of analytical methods and technology within the QC laboratory. Directs and participates in continuous improvement efforts to drive business efficiencies (e.g., TAT improvements, COGM reductions). Directs programs which assure the proper operation and maintenance of laboratory equipment and the timely data analysis and reporting of trends. Participates in the site team, which prepares for, hosts, and responds to regulatory inspections, reviews, and approvals of the facility and products. Accountable for on time completion of quality records within the QMS. Accountable for completion of Annual Product Quality Review and periodic investigation trending reports. Verifies compliance with applicable BMS Policies and Procedures and ensures consistency with other site procedures and/or specifications. Responsible for managing the QC Operations budget. Fosters collaboration and communication across site and network teams. Collaborates with managers across the QC network to harmonize best practices. Performs other tasks as required to support the QC laboratories. Qualifications Specific Knowledge, Skills, Abilities: Ability to work independently and to collaborate cross functionally and at network level to drive operational and quality excellence. Advanced leadership, strategic thinking, critical reasoning, troubleshooting, and decision-making skills to resolve complex scenarios. Advanced mentoring and coaching, influencing, negotiating, and personal interaction skills. Advanced knowledge of regulations and guidelines as related to the manufacture of cell therapy products e.g.: cGMP, ISO, FDA, MHRA, USP, and EP. Experience with method validation and technical transfer. In depth knowledge of QMS and its application to the QC laboratory Advanced verbal and written communication skills with the ability to tailor style for a wide variety of audiences. Experience leading forecasting, capacity modeling, and resource planning. Education/Experience/ Licenses/Certifications: Bachelor’s degree required, preferably in Chemistry, Cell Biology, or related science. Advanced degree preferred. Minimum of 12 years of relevant work experience required Minimum 6 years of increasing management responsibility of a cell therapy, drug product, or related biopharmaceutical Quality Control laboratory. #LI-Hybrid 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. R1604027 : Director, Quality Control