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 has completed an initial public offering (IPO) in February of 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

The Director/Senior Director, GLP/GMP Quality will be responsible for all aspects of Quality Assurance (QA), GLP/GMP compliance, and Quality Control (QC) of the company’s products. The Director will play a pivotal role in ensuring that our operations comply with GLP & GMP regulations, maintaining the highest standards of quality and integrity in our research and development processes.

Essential Duties and responsibilities

• Leadership and Strategy:
  • Develop and implement a comprehensive GLP/GMP quality management strategy aligned with the company's objectives.
  • Provide leadership and direction to the GLP/GMP quality team, fostering a culture of excellence, compliance, and continuous improvement.
• Regulatory Compliance:
  • Stay current with GLP/GMP regulations and guidelines and ensure company-wide adherence to GLP/GMP standards.
  • Maintain a proactive approach to anticipate and address regulatory changes and updates.
• Quality Systems Management:
  • Ensure the Shanghai site aligns with global GLP/GMP quality systems, policies, and procedures; collaborate with the Quality Systems team on system design and development, and provide feedback to support continuous improvement. Collaborate with cross-functional teams to integrate quality practices into laboratory operations.
• Audits and Inspections:
  • Support audit preparation and readiness in partnership with the global Quality team, ensuring timely follow-up on findings while maintaining appropriate independence from vendor relationships.
  • Conduct internal audits to assess GLP/GMP compliance and identify areas for improvement.
• Training and Education:
  • Develop and deliver GLP/GMP training programs to ensure all employees understand and follow GLP/GMP guidelines.
  • Foster a culture of quality awareness throughout the organization.
• Documentation and Recordkeeping:
  • Ensure the accurate and timely documentation of all GLP/GMP-related activities and data.
  • Establish robust recordkeeping practices to meet global regulatory requirements.
• Quality Metrics and Performance:
  • Define key performance indicators (KPIs) to measure and report on GLP/GMP quality performance.
  • Continuously analyze data and metrics to drive process improvements and efficiency.
• Risk Management:
  • Identify potential quality-related risks and develop/drive risk mitigation plans.
  • Collaborate with cross-functional teams to address and resolve quality issues.
• Vendor Management:
  • Oversee vendor quality activities to ensure compliance with GLP/GMP standards and StructureTx expectations.
  • Attend meetings with key vendors to support ongoing operations and ensure alignment on quality expectations.
  • Review and approve vendor batch records, quality events, and related documentation to verify accuracy and compliance.
  • Review and maintain quality agreements to ensure clarity of roles, responsibilities, and adherence to applicable regulatory requirements.

REQUIREMENTS

• A Bachelor's degree in a relevant scientific field is required; a Master's 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.