Clinical QC Manager- Hybrid at Zai Laboratory US

San Diego, California, United States -

Full Time

Start Date

Immediate

Expiry Date

03 Aug, 26

Salary

160000.0

Posted On

05 May, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Quality Control, Clinical Trial Management, ICH-GCP, Risk-Based Monitoring, Root Cause Analysis, CAPA, Inspection Readiness, Protocol Adherence, Site Management, Clinical Operations, Documentation Review, Stakeholder Management

Industry

Biotechnology Research

Description

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 and targeted readiness reviews. Perform targeted reviews of site and study documentation as part of QC assessments to support ongoing inspection readiness. Provide QC summaries and documentation to Clinical Operations leadership and study teams, as requested. Training, Knowledge Sharing, and Operational Improvement Contribute to training activities for Clinical Operations teams based on QC findings, common site execution gaps, and protocol adherence challenges. Incorporate lessons learned from QC activities and regulatory inspections into training, guidance, and study team communications. Identify opportunities for process improvement based on QC observations and trends. Support implementation of applicable SOPs and study processes by reinforcing procedural expectations and providing training or clarification on relevant procedures. Qualifications REQUIRED: Bachelor’s degree in medical science or a related field, with five years’ experience in clinical research, including hands‑on experience with quality‑related activities, such as QC oversight and inspection‑related activities; or equivalent combination of higher education, training and experience. PREFERRED: Deep knowledge and understanding of clinical trial processes and quality management. Strong working knowledge of ICH‑GCP as well as applicable regulations and guidelines. Solid understanding of the skills and knowledge required to deliver a clinical study (e.g., international guidelines, study management, site management, and monitoring). Strong communication and influencing skills: able to communicate effectively and concisely, clearly articulate viewpoints, and align with stakeholders. Demonstrated ability to analyze, interpret, and resolve complex issues. Ability to think strategically and objectively, demonstrating creativity, innovation, and sound judgment. Demonstrated commitment to the highest standards of integrity and ethics. Additional Information The pay range for this position at commencement of employment is expected to be between $140 and $160K/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. At Zai, we are proud of the gender diversity of our company and our promotion of women in biotech. We have achieved gender base pay equity at all levels, 58% of our employees are women and 54% of our management positions are held by women. We are committed to the health of patients and our planet. That’s why our environmental protection, social responsibility, and corporate governance strategy, called “Trust for Life” is integrated within our business. Disclaimer: This description is not intended to be construed as an exhaustive list of duties, responsibilities, or requirement for the position. All personnel may be required to perform duties outside of their normal responsibilities from time to time, as needed. All qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or based on disability. Zai Lab is committed to protecting the privacy and security of the information we collect and to being transparent about the purposes for which we use your information. We have a Privacy Notice which sets forth our policies and practices for handling the information we collect and use in the employment context. Privacy Notice available upon request.

Responsibilities

Conduct independent quality control assessments and on-site visits to ensure clinical trials adhere to protocols, GCP, and company procedures. Identify operational risks and protocol deviations while collaborating with study teams to implement corrective and preventive actions.