Executive Director, Global GCP QA

Structure Therapeutics is seeking an Executive Director, Global GCP QA to lead the Good Clinical Practice (GCP) Quality Assurance team. This pivotal role ensures that all clinical studies comply with global regulations and guidelines, safeguarding patient safety and data integrity. The position reports to the Vice President of Quality and is based in South San Francisco, California.

The Executive Director will act as the primary GCP QA subject matter expert, overseeing compliance across all clinical trials. Key responsibilities include developing and implementing quality audit strategies, providing GCP guidance to clinical study teams and vendors, and making final quality decisions on critical deviations and investigations. The role also involves leading GCP inspection readiness and promoting a culture of quality through effective communication and training.

Candidates must possess a BS or equivalent in a scientific discipline, with an MS or PhD preferred. A minimum of 15 years of progressive experience in Clinical Quality Assurance within global pharmaceutical, biotechnology organizations, or CROs is required, including at least 5 years overseeing outsourced clinical trials and direct GCP auditing experience. Auditor certifications are mandatory, with SQA RQAP GCP credentials preferred. Expertise in GCP and ICH E6(R3) is essential, along with knowledge of 21 CFR Part 11/EU Annex 11 and pharmacovigilance.

The anticipated base salary for this role ranges from $275,000 to $325,000 annually. Additional compensation includes an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Benefits encompass medical, dental, and vision insurance, a 401(k) match, unlimited PTO, and paid holidays, including a winter shutdown.

Structure Therapeutics fosters a collaborative and innovative work environment, emphasizing the development of life-changing medicines through advanced structure-based and computational drug discovery technologies. Employees have the opportunity to contribute to a clinical-stage pipeline focused on chronic diseases with high unmet needs, including cardiovascular, metabolic, and pulmonary conditions.