Senior Manager, GMP Quality Assurance

Structure Therapeutics•South San Francisco, CA

1d•$162,000 - $189,000•Hybrid

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. The Senior Manager, Quality Assurance – Drug Product is responsible for providing quality oversight of outsourced drug product (DP) manufacturing, packaging, labeling, testing, release, and distribution activities across clinical-stage and late-phase development programs. This role serves as the primary QA representative for DP contract manufacturing organizations (CDMOs) and testing laboratories, ensuring GMP compliance and inspection readiness throughout the product lifecycle. The Senior Manager will partner closely with Technical Operations, Manufacturing, Supply Chain, Analytical Development, Quality Control, Regulatory Affairs, and external partners to ensure compliant and uninterrupted supply of investigational medicinal products. This role will also serve as the primary Quality point of contact for Qualified Persons (QPs) supporting EU batch certification and release activities. The ideal candidate will have strong experience with outsourced manufacturing operations, batch disposition, deviation management, and quality oversight of clinical supplies. Experience supporting blinded and randomized clinical studies is desirable. Occasional support of early-phase programs may be required based on business needs.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
8+ years of experience in the pharmaceutical or biotechnology industry, with significant experience in Quality Assurance.
Strong knowledge of FDA, EMA, MHRA, ICH, and global GMP regulations.
Experience supporting batch disposition and release activities for clinical products.
Proven experience overseeing CDMOs and external manufacturing networks.
Working knowledge of EU Qualified Person (QP) certification and batch release requirements.
Experience with batch disposition, deviation investigations, laboratory investigations, change control, CAPA management, and risk management.
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.

Nice To Haves

Experience with blinded, randomized, and placebo-controlled clinical studies is preferred.

Responsibilities

Serve as the QA lead for drug product CDMO oversight, ensuring GMP compliance across manufacturing, testing, packaging, labeling and release activities for late-phase programs.
Provide real-time QA support and decision-making for DP 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 DP 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 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 quality 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 DP manufacturing.
Participate in internal audits and health authority inspections as a subject matter expert for drug product quality.
Provide QA support to early-phase programs as needed, ensuring scalability and consistency of quality practices across development stages.
Support both blinded and unblinded clinical supply operations, including review of labeling and packaging controls designed to maintain study integrity.
Stay current with evolving regulatory requirements and industry trends related to GMP, ICH guidelines, and external manufacturing oversight.