Comm Ops Quality Specialist

Comm Ops Quality Specialist contributes to developing, harmonizing, and enforcing a risk-based Quality Management System (QMS) across clusters, affiliates, and export markets within Commercial Operations Quality. Supports the development, simplification, and implementation of Corporate SOPs, serves as the central quality contact for affiliated entities and direct export markets, ensures consistent application of Corporate SOPs, and coordinates quality activities across the network. Responsibilities include coordinating end-to-end complaints and deviation processes, ensuring accurate recording and timely communication of investigation outcomes, initiating Change Controls and Risk Management per ICH Q9 principles, supporting Health Authority requests and regulatory samples, establishing effective cross-functional communication, providing training and coaching on Corporate Quality System requirements, and contributing to KPI development and monitoring. Requires a university degree in a life-science field, knowledge of GxP, strong communication, organizational, and cross-functional collaboration skills, and proficiency with Microsoft tools and English language. The role operates within Zentiva’s European-centric quality framework with responsibilities spanning clusters, affiliates, representative offices, and direct export markets, with a focus on ongoing quality improvement and regulatory compliance.