Associate Director,Quality Risk Management Job Worcester area,Massachusetts USA,Quality Assurance

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

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.

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Associate Director, Quality Risk Management