Manager of Non-Conformance - Root Cause Analysis/Deviations

Bristol Myers Squibb•Indianapolis, IN

2d•$124,449 - $150,803

About The Position

The Manager, Non-Conformance (NC) / CAPA & Root Cause Analysis builds, leads, and continually improves the site's deviation and non-conformance management and compliance program. Serving as the site's foremost expert in structured root cause analysis (RCA), deep-dive investigations, and corrective and preventive action (CAPA), the manager ensures investigations reach defensible systemic root causes with rigor, consistency, and scientific integrity. The role also supports appropriate adoption of data analytics and AI-enabled capabilities, drives continuous improvement through Lean methods and training, and directly manages the performance, development, and capability building of an investigator team. The manager oversees the full NC/deviation lifecycle, establishes investigation standards, leads high-impact investigations and retrospective reviews, and ensures reports and programs are audit- and inspection-ready. The position partners with IT and Quality Systems on analytics and electronic quality management tools, develops quality metrics for leadership, and leads process improvement, staff training, regulatory responses, and audit support. The role operates in a GMP-regulated manufacturing, laboratory, and office environment. Exposure to radioactive materials is possible, with required radiation safety protocols. PPE is required, and occasional lifting of up to 25 pounds is part of the physical demands. The position is based in Indianapolis, Indiana. The listed starting pay range is $124,449–$150,803 for full-time employees, with potential additional discretionary incentive cash and stock opportunities.

Requirements

Bachelor's degree in Life Sciences, Engineering, Chemistry, Pharmacy, or a related scientific discipline.
At least 8 years of progressive experience in pharmaceutical or biopharmaceutical Quality Assurance.
At least 4 years of experience in non-conformance/deviation management, investigations, and/or CAPA program ownership.
At least 3 years of direct people management experience, including hiring, developing, and managing performance of quality professionals.
Expert-level proficiency in structured RCA methodologies, such as 5-Why, Fishbone, FTA, FMEA, ARCA, and Human Factors Analysis, with openness to other appropriate tools.
Deep knowledge of cGMP regulations and quality system frameworks, including FDA 21 CFR 210/211, ICH Q10, and EU GMP.
Demonstrated experience with an electronic Quality Management System such as Veeva Vault, MasterControl, TrackWise, or equivalent.
Strong analytical and critical-thinking skills to evaluate complex, multi-variable quality events and produce clear, defensible conclusions.
Experience applying Lean, Six Sigma, or other operational excellence methods to quality system improvements.
Excellent written communication skills, including the ability to author technically rigorous, audit-ready investigation reports and regulatory-facing documentation.
Exceptional interpersonal and facilitation skills to lead cross-functional investigation teams with authority and credibility.
Ability to present to senior leadership and regulatory inspectors in high-stakes settings.
Strong coaching and mentoring skills and 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 standard business hours as needed.
Ability to work in a GMP-regulated laboratory or manufacturing environment and use required PPE.
Occasional ability to lift up to 25 pounds.

Nice To Haves

Advanced degree (MS, MBA, or equivalent).
Experience in Biologics, Cell and Gene Therapy, Viral Vector, or similar highly regulated biologics manufacturing environments.
Experience in radiopharmaceutical, aseptic fill/finish, or other sterile manufacturing environments.
Formal Lean or Six Sigma certification, such as Green Belt or Black Belt.
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 subject matter expert for NC/deviations and CAPA.
Ability to apply AI to improve team execution and decision-making.

Responsibilities

Serve as the site subject matter expert and authority for root cause analysis, ensuring investigations identify true, defensible, systemic root causes.
Define, implement, and continually improve the site's RCA framework using appropriate structured investigation methodologies.
Lead and facilitate deep-dive investigations for high-impact, high-risk, and repeat non-conformances and deviations.
Establish standards for investigation depth, scope determination, and evidence gathering.
Conduct cross-functional investigation reviews and challenge assumption-based conclusions in favor of data-supported findings.
Ensure investigation reports are technically accurate, clearly written, and audit-ready in accordance with FDA, ICH Q10, and cGMP expectations.
Lead retrospective reviews of closed investigations to assess the quality and effectiveness of root cause determinations and CAPAs.
Oversee the full non-conformance and deviation lifecycle from initiation and classification through investigation, CAPA assignment, effectiveness verification, and closure.
Partner with IT and Quality Systems teams as the business subject matter expert and requirements owner for analytics and appropriate AI-enabled capabilities.
Provide business requirements and investigative expertise for tools supporting trend detection, deviation classification, and similarity or pattern identification.
Ensure NC and deviation data in the electronic QMS is clean, structured, and consistent for reliable trending and analytics.
Develop and present data-driven quality metrics dashboards to site leadership.
Apply Lean and operational excellence principles to eliminate process waste, reduce investigation cycle time, and improve investigation output quality.
Lead regular deviation and NC trend reviews and quality council presentations, translating data into systemic improvement initiatives.
Promote a proactive quality culture focused on predictive prevention.
Build and sustain a high-performing investigator team through coaching, development plans, and performance management.
Design, develop, and deliver RCA and investigation training for site personnel across roles and functions.
Establish investigation competency standards and certification pathways.
Ensure NC/deviation and CAPA programs remain inspection-ready and meet applicable regulatory expectations.
Lead preparation of NC/deviation responses to regulatory inquiries, Warning Letters, and Form 483 observations.
Serve as a primary subject matter expert and spokesperson for NC/CAPA topics during audit and inspection readiness and conduct.
Maintain current knowledge of regulatory expectations and industry guidance related to deviation and NC management.
Identify and communicate compliance risks and recommend mitigation strategies to Quality and Operations leadership.

Benefits

Wellbeing support.
Retirement and financial protection benefits.
Medical, dental, vision, life, and disability insurance offerings.
Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
Paid vacation for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
11 paid company holidays annually.
Three optional holidays for eligible non-exempt employees, RayzeBio employees, and employees located in Puerto Rico.
Depending on eligibility, 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 may receive an annual Global Shutdown between Christmas Day and New Year's Day.
Potential additional discretionary incentive cash and stock opportunities.