Senior Quality Lead

As a Senior Quality Lead within the Pharma Development Quality (PDQ) 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.

Responsibilities

• Design and implement QA strategies using the Critical to Quality (CtQ) framework across GCP, GVP, and Medical Device areas.
• Define and lead end-to-end audit processes, leveraging data analytics.
• Manage quality issues, track systematic findings, and escalate risks.
• Evaluate quality positions to drive compliance action plans and lead strategic discussions with stakeholders.
• Lead preparation and management of major Health Authority inspections (e.g., FDA, EMA).
• Contribute to PDQ strategic direction and mentor team members.

Requirements

• Extensive background in drug development, clinical trials, and cross-functional experience in GCP, GVP/PV, or Medical Devices/SaMD.
• Proven track record of leading major Health Authority inspections.
• Advanced analytical, critical thinking, and data visualization skills.
• Exceptional relationship management and influencing skills for senior stakeholders.
• Experience leading projects in global, multicultural teams.
• Bachelor’s degree in a scientific or quality-related field (advanced degree preferred).