Clinical Quality Assurance Lead

Job Summary

A company is looking for a Clinical Quality Assurance Lead for an 18-month fixed-term contract.

Key Responsibilities:

• Host and support client audits and regulatory inspections, including preparation and reporting
• Develop and track responses to CAPAs from client inspections
• Collaborate with various teams to conduct audits and manage quality management processes

Required Qualifications and Education:

• University/Bachelor's degree and/or relevant work experience
• 5 years of quality experience in pharmaceutical, medical device, or regulated industries
• A minimum of 2 years' experience hosting GCP audits
• Knowledge of GxP QMS and experience with record management and data analytics
• Willingness to train on regulated eQMS fundamentals