Senior Quality Lead

Senior Quality Lead – Quality Assurance Process & Affiliate Team

As a Senior Quality Lead within our Quality Assurance Process and Affiliate team, you will design and deliver risk‑based Quality Assurance strategies, audits, and conclusions for post‑approval products, affiliates, and processes. You will act as a trusted partner to senior business stakeholders, guiding cross‑functional collaboration to ensure global quality standards are met while navigating complex regulatory landscapes.

• Design and implement QA strategies across GCP, GVP, and Medical Device areas using the CtQ framework.
• Determine audit requirements, develop data‑analytics‑driven audit methodologies, and independently manage the end‑to‑end audit process.
• Manage quality issues, track systematic findings for process improvement, and elevate significant risks to PDQ management.
• Evaluate quality positions to drive compliance action plans and communicate quality con...