Manager of Non-Conformance - Root Cause Analysis/Deviations

Life at BMS At RayzeBio, every day is an opportunity to ignite meaningful change. As a wholly-owned subsidiary of Bristol Myers Squibb, RayzeBio blends the nimble, pioneering spirit of an emergent biotech with the global expertise and resources of a leading innovator in oncology. Our mission is to develop transformative radiopharmaceutical therapies that offer new hope for patients living with cancer. Here, you’ll join a multidisciplinary team where your ideas are valued, your expertise is amplified, and collaboration is at the heart of everything we do. From day one, expect to make an immediate impact—on our science, on our teams, and most importantly, on patients. Learn more about RayzeBio: https://careers.bms.com/rayzebio/ Summary The Manager, Non-Conformance (NC) / CAPA & Root Cause Analysis, is a critical role responsible for building, leading, and continuously improving the site's deviation and non-conformance management and compliance program. This role serves as the site's foremost expert in structured root cause analysis (RCA), deep-dive investigations, and corrective/preventive action (CAPA) creation, ensuring that all non-conformances and deviations are investigated to true root cause with rigor, consistency, and scientific integrity. The Manager will support the thoughtful adoption of data analytics and AI-enabled capabilities into the deviation management lifecycle where they add clear value, and will drive a culture of continuous improvement through Lean methodologies, quality systems training, and cross-functional collaboration. The Manager, NC/CAPA & Root Cause Analysis oversees a team of investigators, directly managing staff performance, development, and capability building across the site. Job Responsibilities Essential duties and responsibilities include the following. Other duties may be assigned. Root Cause Analysis & Deep Investigation Leadership Serve as the site SME and authority for root cause analysis methodology, ensuring all investigations are driven to true, defensible, and systemic root cause — never stopping at proximate or symptomatic causes. Define, implement, and continuously improve the site's RCA framework, incorporating structured tools such as (not limited to): 5-Why Analysis Ishikawa/Fishbone Diagrams Fault Tree Analysis (FTA) Failure Mode and Effects Analysis (FMEA) Is/Is Not Analysis Apollo Root Cause Analysis (ARCA) Human Factors Analysis The Manager is encouraged to evaluate and introduce other RCA tools and methodologies as appropriate to the investigation, and is not limited to the list above. Lead and facilitate deep-dive investigations for high-impact, high-risk, and repeat non-conformances/deviations, including those with potential regulatory, patient safety, or product quality implications. Establish clear standards for investigation depth, scope determination, and evidence-gathering protocols to ensure investigations are thorough, unbiased, and scientifically sound. Conduct cross-functional investigation reviews, challenging investigation teams to eliminate assumption-based conclusions and drive toward data-supported root causes. Ensure investigation reports are technically accurate, clearly written, and audit-ready, meeting FDA, ICH Q10, and cGMP expectations. Lead retrospective reviews of closed investigations to assess quality, consistency, and effectiveness of root cause determinations and CAPAs. Oversee the full non-conformance/deviation lifecycle — from initiation and classification through investigation, CAPA assignment, effectiveness verification, and closure — ensuring timely completion within established metrics and regulatory commitments. Data & Technology Enablement Champion the adoption of data analytics and, where appropriate, AI-enabled capabilities that support the NC/CAPA program, partnering with IT and Quality Systems teams as the business SME and requirements owner. Provide business requirements and investigative subject-matter expertise to IT/Quality Systems teams evaluating tools for trend detection, deviation classification, or similarity/pattern identification across records. Ensure deviation and NC data entered into the site's electronic QMS (eQMS) is clean, structured, and consistent to support reliable trending and analytics. Develop and present data-driven quality metrics dashboards to site leadership, translating NC/deviation trends and compliance KPIs into actionable insights. Lean Methodology & Continuous Improvement Apply Lean and operational excellence principles to the deviation/NC management process to eliminate waste, reduce investigation cycle time, and improve first-time quality of investigation outputs. Utilize Lean tools including: Value Stream Mapping (VSM) to identify bottlenecks and inefficiencies in the deviation lifecycle Plan-Do-Check-Act (PDCA) cycles for process improvement initiatives Kaizen events to drive rapid, targeted improvements to investigation quality and timeliness Statistical Process Control (SPC) and trend analysis to distinguish common-cause from special-cause variation Mistake-Proofing (Poka-Yoke) to design error-resistant processes that reduce recurrence Lead regular deviation/NC trend reviews and quality council presentations, translating data into systemic improvement initiatives. Drive a culture of proactive quality, shifting the site's approach from reactive investigation to predictive prevention. Staff Training, Development & Capability Building Build and sustain a high-performing team of investigators through direct coaching, structured development plans, and performance management. Design, develop, and deliver a comprehensive RCA and investigation training curriculum for the site, covering all levels of staff — from shop floor operators to quality and engineering professionals. Establish investigation competency standards and certification pathways, ensuring all personnel involved in investigations demonstrate proficiency in RCA tools and GMP documentation requirements. Compliance, Regulatory Readiness & Audit Support Ensure the site's NC/deviation and CAPA programs are fully inspection-ready at all times, meeting the expectations of FDA, EMA, and other applicable regulatory bodies. Lead the preparation of deviation/NC responses for regulatory agency inquiries, Warning Letters, and Form 483 observations. Serve as one of the primary SMEs and spokesperson for NC/CAPA-related topics during the readiness for, and conduct of, audits and inspections by regulatory agencies, including but not limited to FDA, EMA, and other applicable authorities. Maintain a current and comprehensive understanding of evolving regulatory expectations and industry guidance related to deviation/NC management, including: FDA 21 CFR Parts 210/211 ICH Q8, Q9, Q10 EU GMP Annex 1