Posted Feb 23, 2026
Position Summary:
Reporting to the Vice President, Quality this position will be responsible for ensuring all clinical studies conducted by Structure comply with all relevant global regulations and guidelines, e.g. (FDA, EMA, NMPA, ICH). The scope of this strategic role covers both sponsor and outsourced activities of clinical trials, developing a high performing team of GCP experts and fostering an understanding and importance of GCP’s across the company, ensuring patient safety and data integrity. Job Responsibilities:
Act as the primary GCP QA subject matter expert and point of contact for all GCP/PV - related matters and issues. - Ensure ongoing clinical trials are compliant with relevant global regulations and guidelines. Develop and support quality audit strategy for all clinical trials, including investigator site audits, Vendor/CRO audits. - Provide quality oversight and GCP guidance to clinical study teams and CROs/vendors to ensure compliance with ICH GCP, applicable regulatory requirements. - Evaluate clinical trial IND/IMPD/NDA enabling documentation, study processes, and operational plans to confirm alignment with relevant global regulations and guidelines. - Final quality decision authority on critical deviations, investigations, and quality risk management in GCP domain with a focus on risk-based thinking and operational efficiency. - Establish appropriate meeting cadence with Clinical Development Operations to leverage cross-department information, identify and correct issues early, and eliminate potential redundancies in activities. - Partner with clinical functions to provide quality guidance and drive the implementation of fit-for-purpose procedures that ensure data and documentation are generated and managed in compliance with GCP. - Work with cross functional teams to assess and manage risks associated with vendors, supporting study compliance, data integrity, and participant safety. - Support the creation, maintenance, and improvement of quality SOPs, manuals, templates, process maps, and approval flows to establish a robust GCP QMS. - Ensure the periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Structure. - Lead GCP inspection readiness, regulatory authority inspections, and partner audits. - Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders. Key Competencies:
Ability to identify and hire excellent candidates possessing the correct skills at the right time and organizational level. - Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment. - Exceptional leadership, project management, and communication skills. - Demonstrated examples of strategic planning with successful outcomes. - Contemporary GCP knowledge of current agency and industry trends, standards, and methodologies
Education/Qualifications:
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