Sr. QC Specialist

Structure Therapeutics•South San Francisco, CA

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 Quality Control (QC) Specialist is responsible for performing comprehensive data quality control (QC) review of analytical data generated by external laboratories and CDMOs supporting drug substance (DS) and drug product (DP) programs from early through late phase development. This role ensures the accuracy, integrity, and compliance of data used for release, stability, and method validation in accordance with GMP and regulatory expectations. The individual will work closely with Quality Assurance (QA), Analytical Development (AD), and Manufacturing to support timely and compliant data review and disposition. This role will also contribute to laboratory investigation reviews and may support data verification activities for regulatory submissions.

Requirements

Bachelor’s degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or related scientific discipline.
7+ years of experience in Quality Control, Analytical Development, or related GxP function within the pharmaceutical or biotechnology industry.
Strong experience reviewing analytical data for small molecule drug substance and/or drug product.
Familiarity with common analytical techniques (e.g., HPLC/UPLC, LC-MS, GC, dissolution, KF, spectroscopy).
Working knowledge of GMP regulations, data integrity requirements, and ICH guidelines.
Experience reviewing stability, release, and method validation data.
Experience with laboratory investigations (OOS/OOT/deviations) and root cause analysis.
Strong attention to detail and ability to identify discrepancies in complex datasets.
Excellent organizational and communication skills with the ability to work cross-functionally.
Ability to manage multiple priorities in a fast-paced environment.

Nice To Haves

Understanding of regulatory submission requirements (IND/NDA) is preferred.

Responsibilities

Perform detailed data QC review of analytical test results from external vendors/CDMOs, including raw data, chromatograms, calculations, and summary reports.
Review and verify data supporting: Drug substance (DS) and drug product (DP) release testing, Stability studies, Method development, qualification, and validation activities.
Ensure data integrity, accuracy, and compliance with GMP requirements, internal procedures, and regulatory expectations (e.g., ALCOA+ principles).
Collaborate cross-functionally with QA, Analytical Development, and Manufacturing to resolve data discrepancies, clarify test methods, and support batch disposition.
Support review of analytical sections of regulatory submissions (e.g., IND, NDA) to ensure data consistency and accuracy.
Participate in and review laboratory investigations (e.g., OOS, OOT, deviations) generated by external vendors; ensure root cause analysis and CAPAs are scientifically sound and compliant.
Track and manage data review timelines to ensure alignment with project schedules and supply chain needs.
Assist in trending and identifying recurring data or quality issues from external labs to support continuous improvement.
Support qualification and oversight of external laboratories by providing QC input for audits and performance reviews.
Contribute to development and improvement of QC procedures, templates, and best practices for external data review.
Support stability program management and testing from external labs to ensure timely pull and testing against approved stability protocols.
Contribute to establishing and extension of shelf life dating.
Maintain clear, thorough, and inspection-ready documentation of all data review activities.
Provide support across multiple programs (early to late phase), adapting to evolving analytical and regulatory requirements.