Clinical Quality Compliance Specialist role in Beijing. Ensure GCP & NMPA compliance, support audits & drive quality improvement. 3+ yrs QA exp in pharma/CRO required. Office-based.
Guardian of Quality: Ensure Excellence in Clinical Research from Our Beijing Hub
ICON plc is a world-leading healthcare intelligence and clinical research organization. Our mission is to accelerate the development of drugs and devices that save lives and improve quality of life through rigorous, compliant, and high-quality clinical trials.
We are seeking a meticulous and proactive Clinical Quality Compliance Specialist to join our Quality & Compliance team in our Beijing office. In this critical office-based role, you will be a key defender of quality standards, ensuring our clinical trials in China and the APAC region adhere to ICH-GCP guidelines, NMPA regulations, and global ICON standards. You will support audits, conduct quality reviews, and collaborate with cross-functional teams to foster a culture of continuous improvement. If you are passionate about quality and compliance and thrive in a structured, collaborative office environment, this is your opportunity to make a significant impact.
Your Mission: The Assurance of Quality and Regulatory Integrity
As a Clinical Quality Compliance Specialist, you will be the operational engine of our local quality management system. Your attention to detail and regulatory knowledge will ensure our processes and documentation are audit-ready and consistently meet the highest standards.
Key Responsibilities
1. Quality Management System & Compliance Support
- Assist in the development, implementation, and maintenance of local quality management systems (QMS) and processes to ensure compliance with NMPA, ICH-GCP, FDA/EMA regulations, and ICON SOPs.
- Provide guidance and support to colleagues on quality compliance matters, promoting awareness of standards and best practices.
- Conduct quality reviews of critical clinical trial documentation, including protocols, study reports, and essential regulatory documents.
2. Audit & Inspection Readiness
- Participate in and support internal audits, external sponsor audits, and regulatory inspections (e.g., NMPA).
- Assist in audit preparation, including documentation gathering, staff briefing, and logistical coordination.
- Contribute to the documentation of findings and the development of robust corrective and preventive action (CAPA) plans.
3. Continuous Improvement & Collaboration
- Collaborate closely with cross-functional teams (Clinical Operations, Regulatory, Data Management) to address quality issues, implement effective CAPAs, and drive process improvements.
- Monitor the implementation and effectiveness of corrective actions.
- Identify trends from audits, inspections, and quality reviews to recommend proactive improvements to systems and training.
Who You Are: The Ideal Candidate
You are a detail-oriented, process-driven professional with a solid grounding in clinical quality assurance. You are an excellent communicator who enjoys working within a structured system to ensure compliance and elevate quality standards.
Your Required Profile:
- Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, or a related healthcare/scientific field.
- Minimum of 3-5 years of direct experience in Clinical Quality Assurance (CQA), Quality Compliance, or a GCP auditing role within a pharmaceutical, biotechnology, or global CRO environment.
- Strong knowledge of ICH-GCP guidelines, Chinese NMPA regulations, and international quality standards.
- Proven experience supporting GCP audits and inspections.
- Exceptional attention to detail and strong analytical skills for reviewing complex documentation.
- Excellent organizational, communication, and problem-solving skills.
- Fluency in English and Mandarin (written and spoken).
- Ability to work effectively both independently and as part of a team in an office-based setting.
What Sets You Apart (Preferred):
- Experience as an auditor or lead in regulatory inspections.
- Formal training or certification in quality auditing.
- Experience with electronic Quality Management Systems (eQMS).
- Knowledge of risk-based quality management (RBQM) principles.
Why Build Your Quality Career at ICON in Beijing?
1. Central Role in a Critical Market
- Be at the heart of ensuring quality and compliance for clinical trials in one of the world's most important and dynamic regulatory environments.
- Gain deep expertise in NMPA regulations while working to global ICH standards.
2. Professional Growth & Development
- Develop a specialized skill set in clinical quality and compliance with opportunities to advance into Senior Specialist, Quality Management, or Regional QA roles.
- Access to global training programs and a network of quality professionals.
3. Office-Based Stability & Comprehensive Benefits
- Competitive salary and performance-based bonus.
- Modern, collaborative office environment in Beijing.
- Generous annual leave entitlements.
- Comprehensive health, life, and retirement benefits.
- Global Employee Assistance Programme and a supportive, inclusive company culture.
Join a Culture Committed to Quality and Inclusion
At ICON, we believe that quality and diversity are inseparable drivers of excellence. We are committed to creating an accessible, inclusive environment and encourage all qualified professionals to apply.
Ready to be the standard-bearer for quality in clinical research in Beijing?
If you are a quality-focused professional passionate about compliance and continuous improvement, apply now to join our Beijing team.
