Associate Director, Global GCP QA

Structure Therapeutics

2h•$165,000 - $210,000•Hybrid

About The Position

Structure Therapeutics develops life-changing medicines for patients using advanced structure-based and computational drug discovery technology. The company’s platform combines the latest advancements in visualization of molecular interactions, computational chemistry, and data integration to design orally available, superior small molecule medicines that overcome current limitations of biologic and peptide drugs. We are advancing a clinical-stage pipeline of differentiated treatments focused on chronic diseases with high unmet need, including cardiovascular, metabolic, and pulmonary conditions. Structure Therapeutics is led by an experienced group of international drug innovators and financed by top-tier global life sciences investors. The company completed an initial public offering (IPO) in February 2023. With offices in California and Shanghai, Structure Therapeutics has the benefit of being at the center of life science innovation in both the US and China and capitalizing on the strengths of each geographic location.

Requirements

BS/MS or equivalent in a scientific discipline required; advanced degree is preferred.
8+ years of pharmaceutical/biotechnology experience, including at least 4 years in GCP QA lead auditor role.
Prior experience in supporting regulatory inspections (FDA, EMA, MHRA, NMPA, PMDA).
Expertise in ICH E6, E8, E2A-F, 21 CFR Part 11, EU Annex 11, and other global standards.
Prior success in executing QMS systems, including vendor management and system implementation.
Working knowledge of EDMS and other document and data management platforms.
Highly organized and detail-oriented, with the ability to manage multiple priorities in a fast-paced, evolving environment.
Exceptional project management, and communication skills.
Bias for action with the ability to drive outcomes across matrixed teams and third parties.
Strong strategic thinking and adaptability in a fast-paced, global environment.

Nice To Haves

Auditor certifications and/or SQA RQAP credentials are preferred.
Prior experience in Big Pharma is preferred.

Responsibilities

Independently provide QA oversight for assigned clinical programs.
Ensure ongoing clinical phase and China clinical programs are in compliance with applicable health authority regulations and guidelines.
Perform review of key Clinical and regulatory submission (e.g. IND/NDA) documents.
Work with cross-functional teams to identify and document risks associated with vendors, supporting study compliance, data integrity, and participant safety.
Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations.
Manage assigned quality events and CAPAs, escalating significant risks appropriately.
Prepare quality metrics and trend analyses for management review.
Support the creation, maintenance, and improvement of quality SOPs, manuals, templates, process maps, and approval flows to establish a robust GCP QMS.
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.
Support the implementation of continuous improvement initiatives across Global QA processes to enhance operational efficiency and maintain high compliance standards.
Support quality improvement projects, supporting clinical operations in improving trial processes and outcomes.
Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholders.
Assist in periodic reporting of key quality metrics to leadership to support continuous improvement in GCP compliance across Structure.
Lead audits for the assigned studies, including internal processes, investigator sites, vendors/CROs, TMFs, and CSRs (both routine and for-cause).
Review and interpret audit findings and ensure effective root cause analysis and CAPAs.
Support GCP-related vendor qualification and oversight, ensuring adherence to global quality standards, contracts and quality agreements.
Evaluate and mitigate compliance risks in GCP domain with a focus on risk-based thinking and operational efficiency.
Support inspection readiness and lead assigned inspection workstreams.
Support global regulatory authority inspections
Maintain a contemporary knowledge of current agency and industry trends, standards, and methodologies related to GCPs.