Clinical QC Manager- Hybrid

Company Description

• Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) is an innovative, research-based, commercial-stage biopharmaceutical company based in China and the United States focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world. Our goal is to leverage our competencies and resources to positively impact human health worldwide.

Founded in 2014, our experienced team has secured partnerships with leading global biopharmaceutical  companies, generating a broad and late-stage pipeline of innovative drug candidates. Based on our proven  track record of  success, Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to not only access the Chinese market but also find a long-term strategic partner for global clinical development.  Our unique business model builds on our in-licensed assets and innovative partnerships to expand our internal discovery and development capabilities and has created a portfolio of potential best-in-class and/or first-in-class therapies. Zai currently has four products on the market in China

Zai Lab was successfully listed on the Nasdaq Stock Market in September 2017 and completed secondary listing on Hong Kong Stock Exchange in September 2020. In 2022, Zai Lab became dual-primary listed on both the Nasdaq and the Hong Kong Stock Exchanges. Since its inception, Zai Lab has expanded significantly with several offices across China. In 2021, Zai Lab established its U.S. Headquarters in Cambridge, Massachusetts.  As of January 2022, the Company has a global team of approximately 2000 employees.

Job Description

Primary Function:

The Clinical QC Manager is a Clinical Operations–based role responsible for conducting independent quality control (QC) assessments to confirm that investigational sites are executing clinical trials in accordance with study protocols, GCP, and company procedures. This role performs targeted, risk‑based QC oversight through on‑site QC visits and focused documentation and process reviews to verify that critical study activities are being performed as intended.

Working in partnership with Clinical Trial Managers (CTMs), CRAs, and other Clinical Operations staff, the Clinical QC Manager independently assesses site execution and protocol adherence and collaborates with the study team on follow‑up actions. The role identifies protocol adherence gaps, recurring operational issues, and process risks, and supports timely follow‑up with accountable owners. This position does not replace routine monitoring activities or serve as the primary site management function; rather, it strengthens study execution by evaluating site processes, identifying trends, and supporting issue resolution across studies.

This position reports to the Executive Director, Head of US Clinical Operations, and is based in our South San Francisco, CA office. Frequent travel to investigational sites is required to support on‑site QC visits and assessments.

Major Responsibilities and Duties:

QC Planning, Assessments, and Reporting

• Develop and maintain study‑specific QC plans, updating based on study progress, complexity, and risk assessment.
• Create and maintain QC tools (e.g., checklists, templates, trackers) to support consistent execution of QC activities.
• Conduct risk‑based, on‑site QC visits to investigational sites to assess protocol adherence and execution of critical study processes (e.g., informed consent process checks, protocol‑required procedures, safety reporting processes, and essential document maintenance).
• Conduct in‑house QC activities (remote or in‑office reviews) as needed, ensuring QC activities are completed within defined timelines and quality expectations.
• Evaluate site processes and documentation to confirm studies are being conducted consistently and as intended.
• Prepare clear, objective QC Visit Reports documenting scope, observations, trends, and required follow‑up actions.
• Escalate significant compliance, patient safety, or data integrity concerns through defined Clinical Operations escalation pathways.

Issue Identification, Follow‑Up, and Trend Analysis

• On a regular basis, in partnership with Clinical Operations teams, identify protocol deviations, recurring site‑level issues, and operational risks through QC activities.
• Support study teams with root cause analysis (RCA) and contribute to the development of corrective and preventive actions (CAPA), as needed.
• Track QC findings and follow‑up actions to closure and contribute to cross‑site and cross‑study trend analysis.

Inspection Readiness Support

• Support inspection readiness activities across preparation, conduct, and follow‑up phases, including self‑checks an