Senior Director, Global GMP Quality Assurance

Structure Therapeutics•South San Francisco, CA

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. We are seeking a Senior Director of GMP Quality Assurance (QA) to serve as a senior quality leader responsible for developing, leading, and executing the global GMP QA strategy in support of a transition from clinical development to commercial readiness. This role verifies compliance with cGMP regulations, company policies and procedures, and industry standards, while deliberately designing quality systems that enable speed, clarity, and confident decision-making as the company scales. The role provides direct oversight of preclinical GLP, early-phase GMP, and late-phase GMP quality operations, ensuring alignment with global quality standards and regulatory expectations. This role partners closely with cross-functional teams and external manufacturing and testing partners ensuring high standards of product quality and data integrity across GMP operations. They build and lead a high-performing GMP QA team, provide strategic oversight of audits and inspections, and serve as a trusted advisor to senior leadership on GMP QA risk management. This position reports to the VP of Global QA.

Requirements

A Bachelor's degree in a relevant scientific field is required
15 + years of experience in GLP/GMP quality management in manufacturing/laboratory or pharmaceutical settings.
Proven leadership and management skills, with a track record of building and leading high-performing teams.
In-depth knowledge of GLP/GMP regulations, guidelines, and industry best practices.
Strong analytical and problem-solving abilities with a results-driven approach.
Excellent communication and interpersonal skills to effectively collaborate with various departments and external partners.
Strong organizational skills and attention to detail.

Nice To Haves

A Master's degree or Ph.D. is preferred.
Certification in Quality Management or relevant fields is a plus.

Responsibilities

Serve as the functional leader for GLP/GMP Quality Assurance and a key member of the Quality Leadership Team, providing strategic direction and oversight for quality activities across nonclinical, clinical, and manufacturing operations.
Lead, develop, and manage the GLP/GMP Quality Assurance and QC Compliance teams, fostering a culture of quality, accountability, collaboration, and continuous improvement.
Build and scale a high-performing quality organization capable of supporting the company's growth from research and development through commercialization.
Develop and execute the GLP/GMP Quality strategy, ensuring alignment with corporate objectives, regulatory expectations, and evolving business needs.
Establish and drive a quality vision that promotes compliance, inspection readiness, operational excellence, scalability, and sustainable business growth.
Provide leadership and oversight of Quality Management System processes, including deviations, investigations, CAPAs, change controls, complaints, product disposition, supplier quality management, and quality risk management.
Ensure compliance with applicable global regulations and standards, including GLP, GMP, FDA, EMA, ICH, OECD, NMPA, and other relevant regulatory requirements.
Provide strategic quality oversight of GLP-regulated nonclinical activities, including toxicology, pharmacology, DMPK, bioanalytical studies, and outsourced preclinical research programs.
Provide strategic quality oversight of GMP manufacturing, testing, and supply activities, including clinical and commercial operations.
Oversee QC Compliance activities, including laboratory investigations, OOS/OOT management, data integrity, analytical method lifecycle compliance, laboratory computerized systems, and inspection readiness.
Lead organizational preparedness for internal audits, regulatory inspections, sponsor audits, and customer audits, ensuring a state of continuous inspection readiness.
Provide strategic oversight of external partners, including CROs, CMOs, CDMOs, contract laboratories, and other GxP service providers.
Establish and maintain effective quality agreements, governance structures, oversight models, escalation processes, and performance metrics to ensure robust oversight of outsourced activities.
Exercise sound judgment and risk-based decision-making in the timely resolution of quality and compliance issues involving internal stakeholders and external partners.
Partner effectively with executive leadership and cross-functional teams to provide quality leadership, compliance guidance, and risk-based recommendations that support development and commercialization objectives.
Lead the preparation, facilitation, and presentation of Quality Management Review meetings, leveraging quality metrics, compliance trends, audit outcomes, and risk assessments to drive informed decision-making, continuous improvement, operational efficiency, and organizational scalability.