Senior Director, Global GMP Quality Assurance

About Us:

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 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:

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 highperforming 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.

Job 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 companys 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.

Qualifications:

• A Bachelors degree in a relevant scientific field is required; a Masters degree or Ph.D. is preferred.
• 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.
• Certification in Quality Management or relevant fields is a plus.

Travel Required: 10-20% travel

Structure Therapeutics Inc. is an Equal-Opportunity Employer.

Structure Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role the anticipated base pay range is $240000-$300000. The exact base pay offered for this role will depend on various factors including but not limited to the candidates geography qualifications skills and experience.

At Structure base pay is only one part of your total compensation package. 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.

Notice to Recruiters/Staffing Agencies

Recruiters and staffing agencies should not contact Structure Therapeutics through this page. All recruitment vendors (search firms recruitment agencies and staffing companies) are prohibited from contacting our hiring manager(s) executive team members or employees.

We require that all recruiters and staffing agencies have a fully executed formal written agreement on file.

Structure Therapeutics receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Structure Therapeutics and such organization and will be considered unsolicited and Structure Therapeutics will not be responsible for related fees.

Fraud Alert

To all candidates: your personal information and online safety are a top priority for us. At Structure Therapeutics direct candidates to apply through our official career page atBambooHR.

Recruiters will always contact you using the domain of . We will never request payments ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Structure Therapeutics please email human resources.

Required Experience:

Exec