Job Description

Locations Czech Republic, Romania, Bulgaria, Poland

Zentiva is a leading European pharmaceutical company committed to delivering high-quality, affordable medicines. Quality, patient safety, and regulatory excellence are at the core of everything we do.

The role
We are looking for an experienced GMP Auditor to join our Corporate Quality team. In this key role, you will help govern critical quality incidents, ensure consistent escalation and reporting across Zentiva, and strengthen compliance with global regulatory and GMP requirements. You will act as a trusted quality partner across manufacturing sites, affiliates, and external partners.

Main Responsibilities

• Lead and manage quality escalations, including assessment, categorization, mitigation, and Health Authority communication

• Provide expert guidance on external audits and regulatory expectations

• Plan, conduct, and document independent audits in compliance with Zentiva’s Quality System and applicable regulations

• Act as a liaison between Quality and business stakeholders to ensure effective issue resolution

• Support regulatory surveillance and Health Authority reporting

• Design and conduct risk-based external audits (CMOs, suppliers, service providers)

• Drive continuous improvement of quality systems, processes, and documentation

• Contribute to corporate quality governance, training, and knowledge sharing

• Traveling within Europe up to 70%

Requirements

• University degree in pharmacy, chemistry, life sciences, engineering, or related field

• 5+ years of experience in GxP / Quality, within the pharmaceutical industry is required

• Strong knowledge of GMP, regulatory requirements, audits, deviations, and change control

• Experience with internal and external audits, and inspections

• Experience working in production site

• Excellent analytical, communication, and stakeholder management skills

• Ability to work independently in a complex, matrix environment

• Fluent English (written and spoken)