Sr. Manager to Associate Director, GMP Quality Assurance

About Us:

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:

Reporting to the Sr.Director of Quality Assurance, this role is responsible for providing strategic and operational quality oversight of Early stage drug substance (DS) manufacturing and testing activities at contract development and manufacturing organizations (CDMOs). The Associate Director will serve as the primary QA point of contact for DS vendors, ensuring GMP compliance, regulatory readiness, and successful execution of clinical and commercial supply.

The Associate Director, Quality Assurance (QA) will lead and oversee quality systems supporting early-stage development activities of DS, including preclinical, CMC, and early clinical (Phase I/II) programs. This role ensures compliance with applicable GxP regulations while enabling efficient and flexible development in a fast-paced biotech environment. The individual will partner cross-functionally with R&D, Clinical, Regulatory, and CMC teams to build phase-appropriate quality frameworks.

Job Responsibilities:

• Serve as the QA lead for drug substance CDMO oversight, ensuring GMP compliance across manufacturing, testing, and release activities for Early-phase programs.
• Provide real-time QA support and decision-making for DS manufacturing campaigns, including batch disposition, deviation management, laboratory investigations, and change control.
• Review and approve key GMP documents, including master batch records, executed batch records, protocols, reports, and specifications.
• Oversee and ensure timely resolution of deviations, investigations, CAPAs, and change controls related to DS activities.
• Act as primary QA interface with CDMOs, fostering strong partnerships while maintaining appropriate quality oversight and compliance expectations.
• Participate in vendor selection, qualification, and ongoing performance management, including audits and quality agreements.
• Collaborate cross-functionally with CMC, Analytical Development, QC, Manufacturing, Regulatory Affairs, and Supply Chain to ensure alignment on DS quality and compliance strategies.
• Support regulatory inspections and filings by ensuring DS-related documentation is inspection-ready and aligned with global regulatory expectations.
• Contribute to development, implementation, and continuous improvement of quality systems, procedures, and best practices related to external manufacturing.
• Mentor and provide technical guidance to QA team members; contribute to building a high-performing QA organization.
• Support risk management activities, including identification and mitigation of quality and supply risks associated with DS manufacturing.
• Participate in internal audits and health authority inspections as a subject matter expert for drug substance quality.
• Stay current with evolving regulatory requirements and industry trends related to GMP, ICH guidelines, and external manufacturing oversight.

Qualifications:

• Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
• 10+ years of experience in the pharmaceutical or biotechnology industry, with significant experience in Quality Assurance.
• Strong experience supporting early development programs (preclinical through Phase I/II)
• Direct Experience in preparation of US and EU IND,NDA filing
• Proven experience overseeing CDMOs and external manufacturing networks.
• Demonstrated knowledge of small molecule drug substance manufacturing and testing processes.
• Experience with batch disposition, deviation investigations, laboratory investigations, change control, CAPA management, and risk management.
• Experience supporting regulatory submissions (IND, NDA, MAA) and health authority inspections.
• Strong cross-functional collaboration skills with the ability to influence without authority.
• Excellent communication, problem-solving, and organizational skills.
• Demonstrated leadership and mentoring capabilities.
• Ability to manage multiple priorities in a fast-paced, dynamic environment.
• Good Spoken in English in addition of writing and reading

Travel Required:

Up to ~20–30% travel, including domestic and international travel to CDMO sites