Manager, Commercial Quality – Europe

This is a fully remote position, open to applicants in Poland.

📋 Description

• Manage Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) for commercial products across the EU and international regions.

• Act as a crucial liaison between cross-functional teams, contract manufacturers, and third-party logistics (3PL) partners.

• Direct the batch review and release processes for commercial APIs, primary packed products, and finished goods.

• Supervise GDP releases following Qualified Person (QP) certification.

• Quickly evaluate, control, and track temperature deviations, discrepancies, and product complaints.

• Guide and resolve significant quality investigations in collaboration with internal and external partners.

• Compose and uphold high-quality agreements with European stakeholders.

• Gather, assess, and present essential quality performance metrics to promote continuous enhancement.

• Work alongside Manufacturing, Supply Chain, and Regulatory teams to address intricate operational issues.

• Engage in the revision of global quality policies and the creation of training materials.

⛳️ Requirements

• At least 3 years of experience in the pharmaceutical or biotechnology sector.

• Robust experience in GMP/GDP quality, preferably at the commercial stage.

• Familiarity with Investigational Medicinal Products.

• Comprehensive understanding of both global and local EU GMP/GDP guidelines and regulations.

• Bachelor's degree in a scientific field (or equivalent practical experience).

• Proficient in English is mandatory; fluency in German is a significant advantage.

• Outstanding interpersonal abilities—excellent listening, writing, negotiation, facilitation skills, and a strong attention to detail.

🏝️ Benefits

• High Visibility & Impact

• Dynamic Scope

• Growth Culture