Associate Director,Quality Risk Specialist – GCP Job Madison area,New Jersey 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.
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.
This will involve partnering with the CAPA CoE and Serious Breach pillar and Clinical Quality Assurance to gather input from audits, inspections, internal quality events, significant issues, and external intelligence to inform QbD.
At the study level, conduct quality assurance 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.
Support for cause, critical and/or complex quality issues as well as serious breaches for the TA, where deemed necessary.
Provide quality and compliance consultation to clinical trials teams throughout study lifecycle.
Provide regulatory intelligence on current and upcoming regulations to ensure we remain compliant with all applicable requirements.
Establish strong partnership with business stakeholders.
Partner with the study teams to ensure effective management of significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors.
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.
Ensure rapid communication and escalation of quality issues, including potential misconduct or issues of significant deviations with project/products, to the business and Health Authorities, as needed.
Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements.
External engagement as needed with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.

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.
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.
Must be able to manage complex assignments/projects and effectively deliver all expected deliverables in a timely manner and proactively communicate changes in pre-established goals and deadlines.

#J-18808-Ljbffr

Associate Director, Quality Risk Specialist – GCP