Associate Director, Quality Risk Specialist; GCP

Associate Director, Quality Risk Specialist (GCP) – RBQM

The Associate Director, RBQM will mainly be responsible for developing the Quality Narrative at the study and/or ASSET and TA levels to document end-to-end RBQM for critical to quality (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.

• 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.
• Partner with Drug Development during the upstream protocol authoring process to embed Quality by Design principles, identify study specific critical to quality (CtQ) data, processes and vendors, and ensure adequate risk mitigation strategies have been implemented.
• Provide feedback on risks to study specific CtQ factors during trial conduct and adjust mitigation strategies when new or unanticipated issues arise.
• Collaborate with the CAPA CoE, Serious Breach pillar, and Clinical Quality Assurance to gather input from audits, inspections, internal quality events, significant issues, and external intelligence to inform QbD.
• Conduct quality assurance spot checks at the study level 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 cause, critical and/or complex quality issues as well as serious breaches for the TA, where deemed necessary.
• Provide regulatory intelligence on current and upcoming regulations to ensure compliance with all applicable requirements.
• Establish strong partnership with business stakeholders, ensuring effective management of significant quality issues/noncompliance and important protocol deviations for CtQ data, processes and vendors.
• Monitor and evaluate 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 significant deviations, to the business and Health Authorities, as needed.
• Ensure compliance with ICH (E8, E6, E9) and other relevant regulatory requirements.
• Engage externally with industry/trade/QA associations, regulatory agencies, vendors, and licensing partners as well as pharmaceutical company peers.
• Drive quality into the business through proactive quality support, mentoring, coaching, and consultation.
• Provide guidance and expectations to the business to enable execution of external and internal regulations on a global and cross-functional level.
• Lead multidisciplinary or cross-functional work/project teams; serve as part of strategic team(s) within the group/discipline.
• Lead and/or contribute to the implementation of large-scale initiatives and/or organizational changes (such as functional optimization) that affect the department.
• Act as a highly credible technical/functional expert; routinely provide technical/functional guidance/coaching to direct and indirect reports/peers within the line or cross lines.
• Influence the external environment through interactions with regulators, trade associations, or professional societies.
• Actively share knowledge with others across multiple disciplines and across lines through existing knowledge sharing processes and systems.

• 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…