Manager of Non-Conformance - Root Cause Analysis/Deviations

Bristol Myers Squibb • Indianapolis, IN

1d

About The Position

The Manager, Non-Conformance (NC) / CAPA & Root Cause Analysis is responsible for building, leading, and continuously improving the site's deviation and non-conformance management and compliance program. The role serves as the site's subject-matter expert for structured root cause analysis, deep-dive investigations, and corrective and preventive actions, ensuring investigations reach defensible, systemic root causes with rigor and scientific integrity. The manager oversees the full non-conformance and deviation lifecycle, from initiation and classification through investigation, CAPA assignment, effectiveness verification, and closure, while ensuring timely completion and regulatory readiness.

The role leads high-impact, high-risk, and repeat investigations; establishes investigation standards; reviews reports and closed investigations; and supports regulatory inquiries, audits, and inspections. It also champions appropriate use of data analytics and AI-enabled capabilities, partners with IT and Quality Systems on eQMS improvements, and presents data-driven quality metrics to site leadership. Applying Lean and operational excellence methods, the manager improves investigation quality and timeliness and promotes proactive quality and prevention.

The manager directly leads a team of investigators, including coaching, performance management, and development. The role designs and delivers site-wide investigation and RCA training, establishes competency standards, and maintains inspection readiness in a GMP-regulated manufacturing, laboratory, and office environment. The position may involve exposure to radioactive materials and requires compliance with radiation-safety protocols.

Requirements

• Bachelor's degree in Life Sciences, Engineering, Chemistry, Pharmacy, or a related scientific discipline.
• At least 8 years of progressive pharmaceutical or biopharmaceutical Quality Assurance experience.
• 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.
• Demonstrated track record leading inspection-ready NC/deviation and CAPA programs with measurable quality improvement outcomes.
• Expert-level proficiency in structured RCA methodologies, such as 5-Why, Fishbone, FTA, FMEA, ARCA, or Human Factors Analysis, and openness to using other tools as appropriate.
• Deep knowledge of cGMP regulations and quality system frameworks, including FDA 21 CFR 210/211, ICH Q10, and EU GMP.
• Experience with electronic Quality Management Systems such as Veeva Vault, MasterControl, TrackWise, or equivalent.
• Strong analytical and critical-thinking skills, including the ability to evaluate complex quality events and develop clear, defensible conclusions.
• Experience applying Lean, Six Sigma, or other operational excellence methodologies to quality-system improvement.
• Excellent written communication skills, including the ability to author technically rigorous investigation reports and regulatory-facing documentation.
• Strong 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.
• 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.
• Ability to work in a GMP-regulated laboratory or manufacturing environment and use required PPE, including protective clothing, gloves, safety glasses, and radiation monitoring devices where applicable.
• Occasional lifting of up to 25 lbs.

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 an NC/deviation and CAPA subject-matter expert.
• Ability to apply AI to improve team execution and decision-making.

Responsibilities

• Serve as the site authority and subject-matter expert for root cause analysis methodology, driving investigations to defensible systemic causes.
• Define, implement, and continually improve the site's RCA framework and select appropriate structured investigation tools.
• Lead and facilitate deep-dive investigations for high-impact, high-risk, or repeat non-conformances and deviations.
• Establish standards for investigation depth, scope, evidence gathering, and scientifically sound, unbiased investigations.
• Conduct cross-functional investigation reviews and challenge assumption-based conclusions.
• Ensure investigation reports are technically accurate, clearly written, audit-ready, and aligned with FDA, ICH Q10, and cGMP expectations.
• Review closed investigations retrospectively to assess root-cause determinations and CAPA effectiveness.
• Oversee the complete NC/deviation lifecycle, including initiation, classification, investigation, CAPA assignment, effectiveness verification, and closure.
• Champion appropriate use of data analytics and AI-enabled capabilities in the NC/CAPA program, partnering with IT and Quality Systems.
• Provide business requirements and subject-matter expertise for tools supporting trend detection, classification, and record similarity or pattern identification.
• Ensure NC and deviation data entered into the eQMS is structured, clean, and consistent for analytics and trending.
• Develop and present data-driven quality dashboards and translate trends and compliance KPIs into actionable insights for site leadership.
• Apply Lean and operational excellence principles to reduce process waste and investigation cycle time and improve first-time quality.
• Lead regular NC/deviation trend reviews and quality council presentations, translating data into systemic improvement initiatives.
• Build a proactive quality culture focused on prevention.
• Manage, coach, develop, and assess the performance of a team of investigators.
• Design, develop, and deliver RCA and investigation training for staff across functions and levels.
• Establish investigation competency standards and certification pathways.
• Maintain inspection readiness for NC/deviation and CAPA programs in accordance with FDA, EMA, and other 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 audits and regulatory inspections.
• Monitor evolving regulatory expectations and guidance and proactively communicate compliance risks and mitigation strategies to Quality and Operations leadership.
• Support critical investigations, audits, and compliance activities outside standard business hours as needed.

Benefits

• Comprehensive benefit plans, including wellbeing support, retirement and financial protection benefits, and insurance offerings.
• Medical, dental, vision, life, and disability insurance offerings, subject to applicable plan terms and eligibility.
• Flexible Time Off without a set accrual limit for eligible U.S.-based exempt employees, subject to manager approval.
• 160 hours of paid vacation annually for new hires for non-exempt employees, RayzeBio employees, and employees located in Puerto Rico, subject to manager approval.
• 11 paid company holidays each year.
• Three optional holidays for 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.
• May be eligible for additional discretionary incentive cash and stock opportunities.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager