Director, Global GCP QA

About Us:

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.
Position Summary:

The Director, Global GCP QA is responsible for governance, compliance oversight, and supporting strategic execution across clinical studies and vendor programs, in compliance with applicable national and international standards, regulations, and guidelines. The position will provide support and promote collaboration internally to ensure all systems; processes, and their outcomes remain compliant. The role will provide expert GCP guidance across global regulatory requirements (FDA, EMA, MHRA, NMPA, PMDA, etc.) and ensure compliance with ICH GCP, FDA, EMA, and other relevant global regulations. The role will collaborate cross-functionally to drive continuous improvement and ensure patient safety and data integrity. This position will report to the Executive Director, Global GCP, QA.
Job Responsibilities
Study Quality Oversight:

- Act as the primary GCP QA subject matter expert and point of contact for all GCP related matters and issues for the assigned early and late phase clinical and China clinical programs.

- Ensure ongoing clinical phase and China clinical programs are in compliance with applicable health authority regulations and guidelines.

- Provide quality oversight and review of key clinical and regulatory submission (e.g. IND/NDA) documents.

- Own and implement the risk-based GCP audit and compliance strategy across the clinical portfolio.

- Establish GCP quality governance forums and provide periodic compliance reports to senior leadership.

- Lead the assessment and escalation of significant quality events, serious breaches, systemic trends, and critical and major CAPAs.

- Monitor adverse trends for the assigned studies. Create and manage issue trends and make recommendations to management.

- Provide strategic oversight of CROs and other critical clinical vendors.

- Manage or mentor GCP QA employees, consultants, and contracted auditors.

- Represent GCP QA in governance committees and major program decisions.

- Work with cross-functional teams to assess and manage 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.

- Support the creation, maintenance, and improvement of quality SOPs, manuals, templates, process maps, and approval flows to establish a robust GCP QMS.

- Drive the implementation of continuous improvement initiatives across Global QA processes to enhance operational efficiency and maintain high compliance standards.

- 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.

- Promote a culture of quality through effective communication, training, and proactive engagement with internal and external stakeholde