Corporate Quality Management System (QMS) Manager

The role of Corporate QMS Manager at Zentiva involves the creation, development, and lifecycle management of the corporate Quality Management System (QMS) across the entire company. The primary responsibility is to ensure compliance with international pharmaceutical regulations, local requirements, and company operational standards in the GxP area. This position plays a crucial role in maintaining and monitoring Zentiva's QMS, driving continuous improvement, and supporting the organization's strategic objectives. Key Responsibilities And Activities: - Actively contribute to the development and implementation of a robust QMS aligned with international standards such as ICH and ISO. - Ensure compliance across all operations and drive the evolution of the QMS to support strategic objectives and business processes. - Standardize processes within the QMS to ensure consistency and efficiency across corporate operations. - Support the preparation of Zentiva Quality Manual, quality strategy, and operational principles for GxP teams. - Stay updated on international regulatory requirements and collaborate with regulatory affairs to address changes. - Write, review, comment, and approve corporate policies within the GxP scope. - Perform regular Quality Reviews between Corporate Quality and Zentiva's QMS sites. - Contribute to developing a learning platform for quality-related topics and continuous improvement. - Establish a framework for implementing Zentiva's QMS at sites, enforce local implementation, and ensure appropriate training. - Participate in internal audits at Zentiva manufacturing sites and affiliates. - Develop and deploy the Data Integrity Prevention Master Plan. - Contribute to implementing risk management practices within the QMS. Other activities: - Assure qualification and validation of all centralized GxP computerized systems in cooperation with IT. - Act as a business quality responsible for corporate IT GxP related projects. - Serve as a quality focal point/back-up for electronic document management systems and the eQMS tool. Qualifications & Required Skills: - Technical University Degree (health, pharma, technical, chemical areas are advantageous). - Minimum 8 years of experience in pharma quality, with knowledge of GxP regulations, process management, and auditing. - Proficiency in English language (written and spoken). - Ability to learn quickly, adapt, analyze, organize, and communicate effectively. - Ability to collaborate with transversal teams effectively. Join Zentiva as a Corporate QMS Manager to play a vital role in ensuring high-quality and affordable medicines reach those who depend on them every day. Your contribution will be instrumental in maintaining compliance, driving continuous improvement, and fostering a culture of excellence within the organization.,