Clinical Ops Quality Lead role in Shanghai. Drive GCP compliance, lead audits & CAPA mgmt for clinical trials. 7+ yrs QA exp in pharma/CRO & deep NMPA knowledge required.
Champion Quality Excellence for Clinical Operations in China
At ICON, we are pioneers in clinical development, dedicated to turning scientific discovery into life-changing therapies. Our commitment to patients is matched by our unwavering commitment to quality, integrity, and regulatory excellence.
We are seeking a strategic and influential Clinical Operations Quality Lead to join our Asia-Pacific Quality team in Shanghai. This is a senior role where you will be the primary quality partner for our Clinical Operations function in China, ensuring the highest standards of GCP compliance and process excellence. You will lead quality oversight, manage complex audits, drive corrective actions, and serve as the key advisor on NMPA regulations and ICH-GCP. If you are a quality leader passionate about building a culture of excellence and continuous improvement, this is your opportunity to shape the quality landscape for clinical trials in a critical market.
Your Mission: Strategic Quality Partner for Clinical Operations
You will be the go-to quality expert, providing strategic guidance and hands-on support to ensure our clinical trials in China are conducted with integrity, are inspection-ready, and comply with all applicable regulations.
Key Responsibilities
1. Strategic Quality Oversight & Advisory
- Serve as the primary Quality point of contact and strategic advisor for Clinical Operations management and teams in China on all GCP and NMPA compliance matters.
- Develop, implement, and maintain robust quality management system (QMS) processes tailored to local requirements and global standards.
- Provide proactive guidance and training on quality standards, risk management, and inspection readiness to foster a pervasive quality culture.
2. Audit & Inspection Leadership
- Plan, lead, and host internal process audits, external vendor audits, and regulatory inspections (e.g., NMPA, PMDA).
- Manage the end-to-end audit/inspection process for China operations: preparation, conduct, response, and CAPA (Corrective and Preventive Action) management.
- Train and coach clinical staff on audit preparedness and conduct mock inspections to ensure ongoing readiness.
3. CAPA Management & Continuous Improvement
- Lead complex investigations into significant quality issues, deviations, and non-conformances, ensuring root cause analysis and effective, sustainable corrective actions.
- Monitor CAPA effectiveness and trends to drive systemic improvements across clinical processes.
- Collaborate cross-functionally with Clinical Operations, Regulatory, and Safety teams to address quality issues and embed quality-by-design into operational plans.
- Analyze quality metrics and KPIs to report on the health of the quality system and identify areas for proactive improvement.
Who You Are: The Ideal Quality Leader
You are an experienced quality professional with deep expertise in GCP and a thorough understanding of the Chinese regulatory environment. You are a diplomatic leader, an effective trainer, and a strategic thinker who can balance compliance with business realities.
Your Required Profile:
- Bachelor’s degree or higher in Life Sciences, Pharmacy, Medicine, or a related field. An advanced degree is a plus.
- Minimum of 7-10 years of progressive experience in Clinical Quality Assurance (CQA) or GCP compliance within a pharmaceutical, biotechnology, or global CRO environment.
- Extensive, hands-on experience with NMPA regulations, ICH-GCP guidelines, and hosting regulatory inspections.
- Proven track record of leading internal and external GCP audits and managing complex CAPA programs.
- Strong leadership, influence, and stakeholder management skills; ability to advise and challenge senior operational leaders effectively.
- Excellent analytical, problem-solving, and communication skills (written and verbal). Fluency in English and Mandarin is essential.
- Detail-oriented, proactive, and able to work independently in a dynamic environment.
What Sets You Apart:
- Professional quality certification (e.g., CQA, RQAP-GCP).
- Experience with Risk-Based Quality Management (RBQM) and electronic QMS (eQMS).
- Direct experience in a Clinical Operations role prior to moving into Quality.
Why Lead Quality for Clinical Operations at ICON in Shanghai?
1. Strategic Impact in a Key Market
- Your leadership directly safeguards the quality and compliance of clinical trials in one of the world's most important and regulated markets.
- Play a critical role in ICON’s growth and reputation for excellence in China.
2. Senior Leadership & Career Growth
- High-visibility role with significant influence across the China clinical organization.
- Clear pathway to Regional Quality Head, Director of Quality, or other senior leadership positions within the global Quality function.
3. Comprehensive Leadership Package
- Highly competitive salary and performance-based bonus.
- Hybrid/office-based role in our modern Shanghai hub.
- Enhanced annual leave and comprehensive health/wellness benefits.
- Global Employee Assistance Programme and dedicated leadership development.
Join a Culture Where Quality is Fundamental
At ICON, we believe that quality is not a department—it is everyone's responsibility, led by experts like you. We are committed to creating an inclusive environment and encourage all qualified quality leaders to apply.
Ready to be the standard-bearer for clinical quality and compliance in China?
If you are a strategic quality leader with deep GCP and NMPA expertise, apply now to join our Shanghai team.
