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 (Aseptic Processing)

• USP <1> and applicable monographs

• PDA Technical Reports (TR54, TR68, etc.)

• Identify and communicate compliance risks proactively, recommending risk mitigation strategies to Quality and Operations leadership.

Education and Experience

• Bachelor's degree (BS) in Life Sciences, Engineering, Chemistry, Pharmacy, or a related scientific discipline required; advanced degree (MS, MBA, or equivalent) preferred.

• 8+ years of progressive experience in pharmaceutical or biopharmaceutical Quality Assurance, with a minimum of 4+ years in non-conformance/deviation management, investigations, and/or CAPA program ownership.

• Minimum 3+ years of direct people management experience, including hiring, developing, and managing performance of quality professionals.

• Experience in Biologics, Cell and Gene Therapy, Viral Vector, or similar highly regulated biologics manufacturing environments preferred; experience in Radiopharmaceutical, aseptic fill/finish, or other sterile manufacturing environments is also valued but not required.

• Demonstrated track record leading inspection-ready NC/deviation and CAPA programs with measurable quality improvement outcomes.

Skills and Qualifications

Required

• Expert-level proficiency in structured RCA methodologies (e.g., 5-Why, Fishbone, FTA, FMEA, ARCA, Human Factors Analysis), with openness to applying other tools as appropriate.

• Deep knowledge of cGMP regulations and quality system frameworks (FDA 21 CFR 210/211, ICH Q10, EU GMP).

• Demonstrated experience with electronic Quality Management Systems (eQMS) such as Veeva Vault, MasterControl, TrackWise, or equivalent.

• Strong analytical and critical thinking skills with the ability to evaluate complex, multi-variable quality events and synthesize clear, defensible conclusions.

• Experience applying Lean, Six Sigma, or other operational excellence methodologies to quality system improvement initiatives.

• Excellent written communication skills — capable of authoring technically rigorous, audit-ready investigation reports and regulatory-facing documentation.

Preferred / Highly Valued

• Formal Lean or Six Sigma certification (Green Belt, Black Belt, or equivalent).

• Familiarity with data analytics or AI-supported quality tools in a GxP environment.

• Experience leading or supporting FDA, EMA, or equivalent regulatory inspections as a SME for NC/deviations and CAPA.
• Applies AI to improve team execution and decision‑making

General

• Exceptional interpersonal and facilitation skills — able to lead cross-functional investigation teams with authority and credibility.

• Comfortable presenting to senior leadership and regulatory inspectors in high-stakes settings.

• Strong coaching and mentoring instincts with a genuine commitment to staff development.

• Ability to manage multiple concurrent investigations and projects in a fast-paced, deadline-driven commercial environment.

• Flexibility to support critical investigations, audits, and compliance activities outside of standard business hours as needed.

Physical Demands

• Ability to work in a GMP-regulated laboratory or manufacturing environment.

• Use of personal protective equipment (PPE) required, including protective clothing, gloves, safety glasses, and radiation monitoring devices where applicable.

• Occasional lifting of up to 25 lbs.

Work Environment

This role operates in a GMP-regulated manufacturing, laboratory, and office environment. Exposure to radioactive materials is possible; all applicable radiation safety protocols and regulatory requirements will be strictly followed. The noise level in the work environment is usually moderate.

We hire for skills and capabilities, not just credentials – if this role excites you, but doesn’t perfectly match your resume, we encourage you to apply anyway.

Indianapolis - RayzeBio - IN: $124,449 - $150,803

The starting pay range(s) listed above is for full-time employees (FTE). You may also be eligible for additional discretionary incentive cash and stock opportunities. We determine starting pay thoughtfully – carefully considering the nature of the role, required skills, work location, schedule and the knowledge and experience you bring. Final compensation is guided by pay equity principles and applicable employment laws. Compensation programs are reviewed on an ongoing basis and may be adjusted over time to reflect evolving market factors, and individual, team or Company performance.

Benefits:

Subject to the terms and conditions of the applicable plans then in effect, you may be eligible to participate in our comprehensive benefit plans – including wellbeing support, retirement and financial protection benefits, and insurance offerings (medical, dental, vision, life and disability).

U.S.-based exempt employees are eligible for Flexible Time Off (FTO), which provides paid time off without a set accrual limit, subject to manager approval, along with 11 paid company holidays each year.

Non-exempt employees, RayzeBio employees, and employees located in Puerto Rico receive 160 hours of paid vacation annually for new hires (subject to manager approval), 11 paid company holidays, and 3 optional holidays.

Depending on eligibility, employees may also have access to additional time-off benefits, including paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs. Eligible employees also enjoy an annual Global Shutdown between Christmas Day and New Year's Day.

U.S.-based job seekers can explore full benefit offerings at https://careers.bms.com/benefits

RayzeBio and Bristol Myers Squibb

RayzeBio was acquired by Bristol Myers Squibb (BMS) in 2024 and is a wholly-owned subsidiary of BMS; however, RayzeBio will continue to operate as a standalone organization.

Supporting People with Disabilities

BMS and RayzeBio are 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 [email protected]. Visit careers.bms.com/eeo-accessibility to access our complete Equal Employment Opportunity statement.

Candidate Rights

BMS and RayzeBio will consider qualified applicants with arrest and conviction records, pursuant to applicable laws in your area.

For roles based in Los Angeles County only:  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/

For roles based in Washington State only: If you live in or expect to work from Washington State if hired for this position, please visit this page for important information about the Washington Fair Chance Act.

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 this posting is missing required information required by local law or incorrect, contact BMS at [email protected] with the Job Title and Requisition number. Do not send application-related inquiries to this email. To check your application status, please login to your Candidate Home Account.

R1607894 : Manager of Non-Conformance - Root Cause Analysis/Deviations