Job Description Summary

The Quality Assurance Leader Germany PDx provides quality leadership and independent quality governance for the German Pharmaceutical Entrepreneur (Pharmazeutischer Unternehmer) and Marketing Authorisation Holder (MAH) activities.

The role is accountable for establishing a robust quality governance framework that ensures compliance with German and EU regulatory requirements, corporate quality standards, and MAH obligations. Acting as the senior quality authority for the German PDx business, the position provides independent quality judgement, drives risk-based decision-making, and influences business strategy to protect patients, product quality, regulatory compliance, and business continuity.

• The role serves as the primary quality partner to senior leadership and works closely with Regulatory Affairs, Pharmacovigilance, Medical Affairs, Supply Chain, Commercial teams, manufacturing sites, and external service providers to ensure quality considerations are effectively embedded across the product lifecycle.