Structure Therapeutics develops lifechanging medicines for patients using advanced structurebased and computational drug discovery technology. The companys 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 clinicalstage 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 has completed an initial public offering (IPO) in February of 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

Structure Therapeutics is seeking a Senior Director, Global Clinical Quality Assurance (CQA) to lead and evolve our global GCP Quality Management System (QMS). This role is responsible for governance, compliance oversight, and strategic execution across clinical development programs. The role will also help define and lead the global CQA strategy aligned with corporate objectives and regulatory expectations. The ideal candidate 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 is based in our South San Francisco (SSF) office, with two core onsite daysTuesday and Thursdayand one additional flexible onsite day.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Quality Governance, Documentation & Systems Development

• Ensure ongoing clinical programs are in compliance with applicable health authority regulations and guidelines.
• Act as the primary GCP QA subject matter expert and point of contact for all GCP/PV-related matters and issues for the assigned program, project, or study.
• Establish and manage the Quality Risk Management program.
• Provide quality oversight and review of key Clinical and IND/IMPD/NDA enabling documents.
• Perform reviews of clinical trial documentation for data integrity and compliance with Good Clinical Practice guidance and regulations. Conduct root cause analysis for recurring issues.
• Support Quality Review meetings' content and material. Prepare and manage Quality KPI and metrics.
• Lead the creation, maintenance, and improvement of quality SOPs, manuals, templates, process maps, and approval flows to establish a robust GCP QMS.
• Perform comprehensive gap assessments across SOPs, processes, and systems to ensure phase-appropriate GCP compliance in an outsourced, risk-based model.
• Champion early engagement of Quality functions during clinical program development, working closely with Clinical Science, Clinical Development Operations, Regulatory Affairs, Medical writing and Pharmacovigilance.

Oversight & Audit Management

• Develop and execute clinical audit strategies, including investigator site audits, vendor/CRO audits, TMF reviews, and CSR audits (both routine and for-cause).
• Review and interpret audit findings and ensure effective root cause analysis and CAPA.
• Oversee GCP-related vendor qualification, management, and audits, ensuring adherence to global quality standards.
• Evaluate and mitigate compliance risks in GCP and GLP domains with a focus on risk-based thinking and operational efficiency.

Inspection Readiness & Compliance Monitoring

• Lead preparation for and support of global regulatory authority inspections and partner audits.
• Investigate quality issues, lead CAPA management, and monitor adverse trends. Provide QA oversight of deviations, quality events, and related metrics across clinical programs.
• Serve as QA representative on cross-functional study teams; review essential study documents to ensure compliance with SOPs and relevant standards (e.g., protocols, ICFs).

Training, Leadership & Strategic Collaboration

• Act as a strategic coach for QA and Clinical leaders and external consultants on quality system implementation and process optimization.
• Serve as a clinical quality subject matter expert during regulatory inspections and cross-functional audits.
• Promote a quality-focused culture through proactive engagement, awareness, and capability-building efforts.

QUALIFICATIONS & REQUIREMENTS

Education

• BS/MS or equivalent in a scientific discipline required; advanced degree (PhD, PharmD) preferred.
• Auditor certifications and/or SQA RQAP credentials strongly preferred.

Experience

• 12+ years progressive experience in Clinical Quality Assurance within global pharmaceutical or biotechnology organizations.
• Minimum 5 years in an outsourced clinical trial model and direct GCP auditing experience.
• Proven leadership in supporting regulatory inspections (FDA, EMA, MHRA, NMPA, PMDA).
• Expertise in GCP, GLP, ICH E6 R3, CFR Part 11, EU Annex 11, and global pharmacovigilance standards.
• Prior success in designing and executing QMS systems, including vendor management and system implementation.
• Working knowledge of EDMS and other document and data management platforms.

Key Competencies

• Exceptional leadership, 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.
• Willingness to travel domestically and internationally (1030%).
  

The target salary range for this full-time role is $255,000 - $306,000 + bonus + equity + benefits. Structure Therapeutics determines salary ranges based on level and scope of responsibilities, as well as location. Individual pay is further determined by additional factors, including relevant experience, specific job skills, education and training. More details about the specific salary range for your location will be discussed with you during the hiring process by the StructureTx Talent Acquisition Team.