Sr. QC Specialist

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:

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.

Job 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.

Qualifications: 

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

Travel Required:

Minimal travel required; occasional travel to external vendors may be needed.

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 $140,000 - $175,000. 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

Recruiters and staffing agencies should not contact Structure Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees.

We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file.

Structure Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Structure Therapeutics and such organization and will be considered unsolicited and Structure Therapeutics will not be responsible for related fees.

Fraud Alert

To all candidates: your personal information and online safety are a top priority for us. At Structure Therapeutics, direct candidates to apply through our official career page at BambooHR.

Recruiters will always contact you using the domain of Structuretx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Structure Therapeutics, please email human resources.