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)
