Associate Director, Quality Risk Management

Bristol Myers Squibb

. Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.

Posted 5/22/2026full-timePrinceton • Massachusetts, New Jersey • 🇺🇸 United StatesSenior💰 $175,310 - $212,438 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud Platform

About the role

Key responsibilities & impact

Develop the Quality Narrative (or equivalent) at a study and/or ASSET and TA level, to document the end-to-end risk-based quality management for CtQ data, processes and vendors demonstrating effective risk and issue management.
Provide quality and compliance consultation to clinical trials teams throughout study lifecycle and establish a feedback loop to ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.
As part of the upstream protocol authoring process, partner with Drug Development to embed Quality by Design principles and help identify study specific critical to quality (CtQ) data, processes and vendors and ensure adequate risk mitigation strategies have been implemented.
During trial conduct, provide feedback on risks to study specific critical to quality factors and ensure mitigation strategies are adjusted when new or unanticipated issues arise once the trial has begun.
Conduct spot checks to ensure risk mitigation strategies are accurately translated into operational plans.
Assist the business in defining and establishing Acceptable Ranges/QTL and KRIs for CtQ data.
Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.
Support the monitoring and evaluation of CtQ factors throughout the study lifecycle and adapt Quality plans accordingly.
Provide R&D Quality expertise, critical thinking, deliver training and share best practices and lessons learned into future trials.

Requirements

What you’ll need

B.S. and/or M.S. in Chemistry, Biology, or Health or Quality related field or equivalent combination of education, training, and experience
Minimum 8+ years QA experience or relevant experience in quality management, biomedical science, clinical development, or regulatory compliance.
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 – Hematology, Oncology, Cell Therapy, Immunology, Cardiology and Neuroscience.
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.

Benefits

Comp & perks

Health Coverage: Medical, pharmacy, dental, and vision care.
Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP).
Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support.
Paid Time Off US Exempt Employees: flexible time off (unlimited, with manager approval, 11 paid national holidays (not applicable to employees in Phoenix, AZ, Puerto Rico or Rayzebio employees) Phoenix, AZ, Puerto Rico and Rayzebio Exempt, Non-Exempt, Hourly Employees: 160 hours annual paid vacation for new hires with manager approval, 11 national holidays, and 3 optional holidays
Based on eligibility*, additional time off for employees may include unlimited paid sick time, up to 2 paid volunteer days per year, summer hours flexibility, leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs and an annual Global Shutdown between Christmas and New Years Day.

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

Quality Narrative developmentrisk-based quality managementregulatory compliancerisk assessmentrisk analysisrisk evaluationrisk reportingrisk treatmentclinical research processesQuality Assurance principles

Soft Skills

critical thinkingproblem-solvinganalytical capabilityconceptual capabilitycommunicationcollaborationfeedback provisiontraining deliverybest practices sharingadaptability