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About the Role

The Clinical QC Manager is 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.

Responsibilities

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.
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.
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.
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.
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.

Requirements

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.
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.

Skills

Quality control
GCP
Clinical trial management
Risk assessment
Documentation review
Root cause analysis
Corrective and preventive actions (CAPA)
Inspection readiness
Process improvement
Communication
Influencing
Analysis
Problem-solving
Strategic thinking
Integrity
Ethics

Location

Remote

Work Type

Remote
Full-time

Experience Level

5 years experience in clinical research

Education Level

Bachelor's degree in medical science or a related field

Salary/Compensations

$140,000 - $160,000

Benefits

Sign-on bonus
Restricted stock units
Discretionary awards
Medical benefits
Financial benefits
401(k) eligibility
Paid time off (vacation, sick time, parental leave)

About the Company

Zai Lab Limited is an innovative, research-based, commercial-stage biopharmaceutical company focused on bringing transformative medicines for oncology, autoimmune disorders, infectious diseases, and neurological disorders to patients in China and around the world.
The company has secured partnerships with leading global biopharmaceutical companies, generating a broad and late-stage pipeline of innovative drug candidates.
Zai Lab has earned the reputation as a trusted partner of choice for global biopharmaceutical companies seeking to access the Chinese market and find a long-term strategic partner for global clinical development.
The company's unique business model builds on in-licensed assets and innovative partnerships to expand internal discovery and development capabilities.
Zai Lab 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 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.

Equal Opportunity

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 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.