structuretx

structuretx

Senior Director, Global GMP Quality Assurance

South San Francisco, California · Director

Sponsorship not specified$10k-$20kDetected 20 days ago
PharmacologyGMPFDA RegulatoryResearchAnimal StudiesLeadershipCommunicationCollaborationProblem SolvingOrganizational SkillsGxP

About the role

  • 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 position reports to the VP of Global QA.

Responsibilities

  • 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.
  • 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.

Requirements

  • 15 + years of experience in GLP/GMP quality management in manufacturing/laboratory or pharmaceutical settings.
  • In-depth knowledge of GLP/GMP regulations, guidelines, and industry best practices.
  • Travel Required: 10-20% travel
  • If you are unsure if a message is from Structure Therapeutics, please email human resources.
  • Proven leadership and management skills, with a track record of building and leading high-performing teams.
  • 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.
  • 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 $240,000-$300,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate's 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

Nice to have

  • A Bachelor's degree in a relevant scientific field is required
  • a Master's degree or Ph.D. is preferred.
  • Certification in Quality Management or relevant fields is a plus.

Compensation

  • For this role, the anticipated base pay range is $240,000-$300,000.

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.
  • Establish and drive a quality vision that promotes compliance, inspection readiness, operational excellence, scalability, and sustainable business growth.

Company info

  • 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.
  • 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.
  • 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 partners closely with cross-functional teams and external manufacturing and testing partners ensuring high standards of product quality and data integrity across GMP operations.

Visa & Work Authorization

  • Lead organizational preparedness for internal audits, regulatory inspections, sponsor audits, and customer audits, ensuring a state of continuous inspection readiness.
Apply directly at structuretx →Create a free account for alerts like thisView structuretx immigration profile

This listing is sourced directly from structuretx's careers page and normalized into a canonical job model.