Sr. Manager, Clinical Quality Assurance

Role: Quality Assurance Lead supporting Summit’s clinical and preclinical oncology programs, ensuring GxP compliance across global trials. Responsibilities: partner with R&D teams to provide quality oversight, manage audits (clinical sites, vendors), lead CAPAs, support inspections and regulatory interactions, and develop quality plans aligned with clinical development strategies. Qualifications: Bachelor's in Life Sciences, Pharmacy, or Nursing; 5+ years in QA or regulated clinical operations; deep knowledge of GCP, GLP, FDA/EU regulations, and international guidelines; experience with global clinical trial management and regulatory inspections. Preferred: Master’s degree, Mandarin fluency, 5+ years in Oncology or related therapeutic areas, and proficiency in electronic document systems. High-Value: Oncology (NSCLC, CRC), Phase 3 trials, global regulatory compliance, audit management, inspection readiness, cross-functional collaboration with R&D, QA, Regulatory, and external vendors. WorkSetup: likely hybrid or remote with up to 20% travel.