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.Qualifications - Education and Experience: B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience Minimum 10+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance. Knowledge, Skills, and Abilities: Demonstrated applied knowledge of ICH/GCP, regulatory guidelines/directives, clinical research processes and principles of Quality Assurance Very experienced in Risk Based Quality Management principles. In-depth knowledge of applied risk-management including risk assessment, risk analysis, risk evaluation, risk reporting and communication, risk treatment and the review of continuous risk management Understanding of BMS's therapeutic areas - HOCT (Hematology, Oncology, Cell therapy) and ICN (Immunology, Cardiovascular, Neurosciences). Extensive experience in regulatory inspection preparation, management, and related follow-up. Demonstrated analytical and conceptual capability-including proficiency in utilizing data and ability to formulate clear business questions that can be answered with data. Proven problem-solving skills to prevent and overcome complex process and quality related issues during clinical program implementation and execution. Communication Skills: Communicates professionally, clearly, concisely and consistently both verbally and in writing to internal and external customers; excellent presentation skills for compelling peer and Senior Management communication. Project Management: Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines. Considers global influences, situations, and implications when making plans or decisions, solving problems, or developing strategies. Responds resourcefully to changing business conditions and opportunities, proactively looking for ways the organization can adapt its plans, tactics, or strategies. Fosters a culture in which people continually work to improve services, and work processes. Key Responsibilities: Ensure Quality Strategies for HOCT (Hematology, Oncology, Cell therapy) and ICN (Immunology, Cardiovascular, Neurosciences) studies are developed to avoid, detect and address serious non-compliance with GCP, the trial protocol and applicable regulatory requirements to prevent recurrence. Oversee development of the Quality Narrative (or equivalent) at a study and/or ASSET / TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management. Manage a team of Quality Risk Leads and oversee team performance, provide guidance and development opportunities, ensuring operational efficiency and alignment with departmental and organizational objectives. Partner with CORM to drive adoption of Quality by Design principles across BMS protocols to ensure quality is built into the scientific and operational design and conduct of clinical trials. Ensure risks to critical to quality factors are managed prospectively and adjusted when new or unanticipated issues arise once the trial has begun. Provide leadership, guidance, development and coaching to the RBQM team for management of significant quality issues. Lead for cause, critical and/or complex quality issues as well as serious breaches for the TA, if needed. Provide R&D Quality expertise, critical thinking, and partner with Drug Development to deliver training and education to support effective RBM practices. Establish strong partnerships with business stakeholders and participate in GPT / CDT / other relevant governance committees for the ASSET. Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed. Define, own, and execute R&D Quality processes contributing to Drug Development's end-to-end Risk Based Management (RBM) framework across the clinical trial portfolio. Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements. External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers. Other: Drive quality into the business through proactive quality support, mentoring and/or coaching and consultation. Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross functional level. Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline. Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes that affect the department. Act as a highly credible technical/ functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or crosslines. May influence the external environment through interactions with regulators, trade associations, or professional societies. Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems. On-site Protocol BMS has a diverse 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 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. 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. BMS cares about your well-being and the well-being of our staff, customers, patients, and communities. As a result, the Company strongly recommends that all employees be fully vaccinated for Covid-19 and keep up to date with Covid-19 boosters. #J-18808-Ljbffr