Manager, Clinical Quality Assurance (CQA)

Responsibilities

• Represent CQA as a Global Quality Lead (GQL) on assigned R&D asset and study teams
• Develop Clinical Quality Assurance Oversight Strategies, including audit plans and risk assessments
• Conduct audits of clinical study sites, vendors, and internal systems to ensure GCP compliance
• Support regulatory inspection readiness and manage the rollout of inspection readiness programs
• Manage quality issues related to nonconformances, scientific misconduct, or potential fraud
• Track and report quality metrics to management to ensure compliance with regulatory requirements
• Support the development and implementation of process improvements within R&D QA

Requirements

• Bachelor's degree in sciences
• Minimum of 3 years of experience in the pharmaceutical or biotechnology industry
• Minimum of 1 year of experience in Quality Assurance (QA)
• Minimum of 2 years of project management or clinical monitoring experience
• Strong understanding of GCP requirements and clinical quality assurance processes
• Proficiency in Microsoft Office and effective English communication skills
• Ability to travel 20-35% as required (primarily to the US)

Benefits

• Hybrid working solution allowing for flexibility between office and home work
• Opportunity to work within a Global Capability Centre (GCC) environment

About the Company

Astellas is a global pharmaceutical company dedicated to turning innovative science into value for patients. Our Global Capability Centres (GCCs) in India, Poland, and Mexico enhance our operational efficiency and innovation potential, supporting our commitment to sustainable growth and scientific excellence.