Executive Director, Global GCP QA

Structure Therapeutics • South San Francisco, CA

9h • $275,000 - $325,000

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.
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.

Requirements

• 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
• BS, or equivalent, in a scientific discipline required; MS or PhD degree is preferred.
• Auditor certifications required; SQA RQAP GCP credentials are preferred.
• 15+ years of progressive experience in Clinical Quality Assurance within global pharmaceutical, biotechnology organizations, or CRO.
• Minimum 5 years overseeing outsourced clinical trial model and direct GCP auditing experience.
• Proven leadership leading GCP regulatory inspections.
• Expertise in GCP and ICH E6(R3); knowledge of 21 CFR Part 11/EU Annex 11, and pharmacovigilance a plus.
• Prior success in designing and implementing electronic quality management system (eQMS) and electronic document management system (eDMS).
• Travel Required: Typically, 20% based on business needs.

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.

Benefits

• The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity.
• Structure Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, unlimited PTO, and a number of paid holidays including winter shutdown.

What This Job Offers

• Job Type: Full-time
• Career Level: Executive