CQA Team Leader
Core
Leads and supervises a team of auditors to ensure clinical projects are supported through independent clinical audit assessments, inspection management, quality reviews, and GCP advice.
Role type
Senior management-level Clinical Quality Assessment (CQA) Team Leader
Builds
Independent clinical audit assessments, inspection management processes, and quality review frameworks for clinical trials
Domain
Biopharmaceutical R&D / Clinical Quality Assessment / Regulatory Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Clinical Quality Assessment, Clinical Trial Management, GCP regulations, Team Leadership, Audit Planning, Risk Management, Data Analytics, Digital Transformation, Agile Methodologies
Preferred skills
Predictive analytics, AI/ML for data insights, Digital workflow optimization, Change management
Technologies
Clinical trial management systems, eClinical platforms, Data visualization tools, Digital collaboration platforms
Responsibilities
Oversee day-to-day performance, coaching, and training of the audit team; Lead audit planning and strategy development; Coordinate and support regulatory inspection activities; Implement data quality control measures leveraging AI and machine learning; Develop and update quality policies and procedures; Manage business support staff and performance objectives.
Seniority
Senior, hands-on IC with management responsibilities
