Manager, Quality Assurance Investigations

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 rich in diversity. 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: Manager, Quality Assurance Investigations Location: Warren, NJ 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 Quality Assurance Investigations Manager is responsible for providing Quality Assurance oversight on deviation investigations to ensure the written investigation report contains the technical merit and completeness according to regulatory expectations. This position will be responsible for operating cross-functionally, reviewing necessary data and information associated with site deviations. This position will participate in root cause analysis sessions with lead investigators/SME’s and determine the associated corrective action to prevent the deviation from recurring. This position reports to the Senior Manager of Quality Assurance Event Management Key Responsibilities Responsible for the Quality Assurance GMP deviation investigation approval at Warren, NJ and ensuring adherence to applicable GMP regulations and BMS policies and procedures Provide consistent direction and ensure timely completion of deviation investigations to ensure on-going consistency for investigation reports that will stand alone during regulatory inspections. Collaborate with stakeholders and management, and communicate investigation status to management as appropriate Develop the necessary skills using the appropriate tool(s) and statistical application in risk management and Root Cause Analysis to enable the effective and timely close of deviation investigations. Apply knowledge of quality processes, including, triaging of deviations, investigations, CAPA, and product complaints. Review of GMP documentation, deviations, customer complaints and CAPAs as required. Performs supplemental investigations/projects as required by senior management. Responsible for ERP Material Status Changes of production/drug product due to deviating events. Act as subject matter expert for QA oversight of GMP deviation investigations during regulatory inspections. Manage the resolution of root cause investigations, including impact assessments, and CAPAs as a Quality Approver Collaborate with many different groups/organizations as a Quality Approver including but not limited to Process Engineering and Support, Engineering and Facilities, Manufacturing Operations, Manufacturing Science and Technology, and Quality Control Train and qualify deviation investigators on root cause analysis tools per written procedures Mentor and coach deviation owners/investigators Write deviation trend reports per written procedures Proactively manage the progression of investigations and CAPAs to timely and compliant closure per established KPIs Present investigation findings to key stakeholders and site senior management Utilize Quality Risk Management principles to facilitate risk-based decision-making, drive continuous improvement, and eliminate waste Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory inspections Staying current with industry trends and BMS standards and participating in best practice forums consistent with function responsibilities. Qualifications and Experience B.S. degree required Minimum of 8 years of experience in the pharmaceutical or related industry with minimum, 3 years in Quality Assurance Equivalent combination of education and experience acceptable. Strong knowledge of cGMP Quality and Compliance principles required. Clinical and Phase appropriate experience preferred. Strong cross-functional collaboration experience required Must have GMP, Quality, and in-depth risk management knowledge. Must have strong authorship and be able to critically review investigations and reports, interpret results, generate technical conclusions consistent with Quality risk management principles. Requires minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consults with manager for decisions outside established processes; authority to make daily decisions that impact team. Routinely recognizes and resolves Quality issues; informs management of proposed solutions. Seeks management guidance on complex issues; develops procedures. Must be action-oriented and customer-focused and skilled in decision making, building relationship, problem solving, conflict management, planning and organizing, and analytical thinking. Able to prepare written communications and communicate problems to management with clarity and accuracy. Experience in utilizing root cause analysis tools and identifying corrective and preventive actions Experience with Operational Excellence and Lean Manufacturing is a plus Experience in cell therapy, biologics, or vaccine manufacturing/support desired Experience in cell therapy quality control laboratory is a plus Experience with flow cytometry techniques (Canto) is desired Experience with Interim Disposition Assessments or Exceptional Release for Cell Therapy Drug Products is a plus Experience with Infinity Quality Management System is a plus Experience in cGMP’s and multi-national biopharmaceutical/cell therapy regulations desired Excellent verbal/written communication skills and ability to influence at all levels Ability to think strategically, and to translate strategy into action Ability to prioritize and provide clear direction to team members in a highly dynamic environment Must be skilled in planning and organizing, conflict management, coaching others, decision-making, building relationships, innovation management, and resource allocation. Able to conceptualize impact of Quality initiatives in terms of cross-functional teams Requires minimal direction to complete tasks, knows how to get resources and information from established internal contacts; consults with supervisor for decisions outside established processes. Routinely recognizes and resolves Quality issues; Seeks management guidance on complex issues; develops procedures. Able to interpret complex results and situations with degree of independence and articulate recommendations for solutions. Recognizes risk and develops contingency plans. Negotiates solutions cross-functionally. Drives continuous improvement and improves efficiency and productivity within the group or project. Why You Should Apply 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. Our company is committed to ensuring that people with disabilities can excel through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or any part of the recruitment process direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.
LI-Onsite BMSCART VETERAN 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 an inclusive culture, promoting diversity 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 Physical presence at the BMS worksite or physical presence in the field is a necessary job function of this role, which the Company deems critical to collaboration, innovation, productivity, employee well-being and engagement, and it enhances the Company culture. COVID-19 Information To protect the safety of our workforce, customers, patients and communities, the policy of the Company requires all employees and workers in the U.S. and Puerto Rico to be fully vaccinated against COVID-19, unless they have received an exception based on an approved request for a medical or religious reasonable accommodation. Therefore, all BMS applicants seeking a role located in the U.S. and Puerto Rico must confirm that they have already received or are willing to receive the full COVID-19 vaccination by their start date as a qualification of the role and condition of employment. This requirement is subject to state and local law restrictions and may not be applicable to employees working in certain jurisdictions such as Montana. This requirement is also subject to discussions with collective bargaining representatives in the U.S. BMS is dedicated to ensuring that people with disabilities can perform complex functions through a transparent recruitment process, reasonable workplace adjustments and ongoing support in their roles. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application, or in any part of the recruitment process, direct your inquiries to [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement. BMS will consider for employment qualified applicants with arrest and conviction records, pursuant to applicable laws in your area. Any data processed in connection with role applications will be treated in accordance with applicable data privacy policies and regulations.