Regional Quality Assurance Specialist – Eastern Europe (Remote)

LEO Pharma; Gdańsk; Hybrid; PLN 140.000 - 190.000; Vollzeit

Zusammenfassung

LEO Pharma is seeking a Quality Assurance Specialist based in Poland to map and build quality processes across Eastern Europe. You will ensure GDP/GxP oversight in line with global procedures and collaborate with affiliates, 3PLs, and partners.

You will maintain local GxP Quality Management Systems, support audits, training, deviations, CAPAs, and supplier qualification. The role requires a degree in life sciences and about 4 years in pharmaceutical quality or distribution, with business-fluent

Qualifikationen

• Degree in pharmacy, biology, chemistry, life sciences, or similar is preferred.
• Approximately 4 years of experience in pharmaceutical quality or distribution, supply chain.
• Good understanding of GDP requirements and pharmaceutical distribution models; knowledge of GMP and Eastern European GxP environments is an advantage.
• Experience with eQMS tools such as Veeva, TrackWise, or similar systems is an advantage.
• Business-fluent English, both written and spoken, and knowledge of an Eastern European language is an advantage.

Aufgaben

• Map quality responsibilities, warehouses, 3PLs, wholesalers, partners, and key contacts across assigned Eastern European countries.
• Support and maintain local GxP Quality Management Systems, including training compliance, documentation, SOPs, work instructions, deviations, CAPAs, complaints, recalls, and returns.
• Act as the primary quality contact for warehouses, wholesalers, affiliates, and partner markets when quality issues such as temperature excursions, product breakage, deviations, complaints, or returns occur.
• Maintain quality agreements, support supplier qualification and audits, and help ensure inspection readiness across the region.
• Contribute to quality process improvements and global projects.

Kenntnisse

GDP/GxP understanding

English proficiency

Quality mindset

Ausbildung

Degree in pharmacy, biology, chemistry, life sciences, or similar

Tools

Veeva

TrackWise

Jobbeschreibung

LEO Pharma is seeking a Quality Assurance Specialist based in Poland to map and build quality processes across Eastern Europe. You will ensure GDP/GxP oversight in line with global procedures and collaborate with affiliates, 3PLs, and partners.

You will maintain local GxP Quality Management Systems, support audits, training, deviations, CAPAs, and supplier qualification. The role requires a degree in life sciences and about 4 years in pharmaceutical quality or distribution, with business-fluent