Corporate Quality Management System (QMS) Manager

POSITION PURPOSE Zentiva is a Pan-European Platform developing, manufacturing, and providing high-quality and affordable medicines to more than 100 million people in Europe. Zentiva has 4 wholly owned manufacturing sites and a broad network of external manufacturing partners to ensure supply security. We are offering solutions in key therapeutical areas like Cardiology & Circulation, Diabetes, Oncology, Respiratory, CNS and focus on expanding our portfolio in self-care. The company is Private Equity owned, delivering sustainable double-digit growth, with an ambitious 5-year plan for further strong (organic and inorganic) growth across Europe. We are a team of almost 5,000 unique talents bonded together by our mission to deliver high-quality and affordable medicines to people who depend on them every day. We want Zentiva to be a great place to work, where everyone feels welcomed and appreciated, and can be their true selves contributing to the best of their ability.

The role of Corporate QMS Manager is creation, development and lifecycle management of corporate QMS within whole company and its oversight. Also to assure compliance of the QMS with international as well as local pharmaceutical regulations and company operative requirements in GxP area.

KEY RESPONSIBILITIES AND ACTIVITIES
QMS Development and Implementation:

• Actively contributes to the development and implementation of a robust QMS aligned with international standards such as ICH and ISO, ensuring compliance across all operations. Drive the evolution of the QMS to support the organization's strategic objectives and business processes.
• Assure QMS lifecycle management and development according to actual legislative requirements. Maintain and monitor Zentiva’s QMS including continuous improvement.
• Standardize processes within the QMS to ensure consistency and efficiency across corporate operations. Continuously assess and optimize quality processes to enhance productivity and quality outcomes.
• Support preparation of Zentiva Quality Manual, quality strategy and basic operational principles of all GxP relevant teams.
• Responsible for creation of corporate policies and operational guidelines for quality area and review and approval of other GxP relevant policies and guidelines of other GxP relevant corporate teams.
• Stay updated on international regulatory requirements relevant to the pharmaceutical industry and ensure alignment of the QMS. Collaborate with regulatory affairs to proactively address changes in regulations and guidelines.
• Initiate and coordinate regular revisions and archiving of corporate quality documents.
• Write, review, comment, and approve corporate policies, or guideline within GxP scope.
• Acts as quality responsible for deviations, change controls or other quality events opened by corporate departments.
• Perform regular Quality Reviews between Corporate Quality and Zentiva’s QMS sites, follow up GxP compliance status and trends.
• Contribute to develop learning platform for all quality related topics, including cultural aspects – proactive mindset, problem solving and root causes analyses and any other relevant methods/tools to be applied to permanently improve the performance of our operations.
• Establish a framework for implementation of Zentiva’s QMS (incl. corporate QMS documents) at Zentiva sites, enforce local implementation and ensure appropriate trainings.
• Participate in internal audits at Zentiva manufacturing sites and affiliates.
• Develop and deploy the Data Integrity Prevention Master Plan to safeguard our license to operate.
• Participate in cross-functional projects and act as stakeholder for Zentiva Corporate Quality
• Assure that development, site, and affiliate quality teams are adequately trained in Zentiva Quality System and Regulatory requirements and organizing appropriate trainings if needed.
• Assure definition of shared key Zentiva processes, their creation in the eQMS tool, further lifecycle management, development, and operational end user support at operational level.
• Contribute to implementing risk management practices within the QMS to identify, assess, and mitigate risks associated with product quality and regulatory compliance. Drive initiatives to proactively address potential risks and enhance the resilience of the quality systems.

Other activities

• Assures qualification and validation of all centralized GxP computerized systems in cooperation with IT.
• Acts as a business quality responsible for corporate IT GxP related projects related to computerized systems (definition of optimal project strategy from a quality point of view, responsibility for fulfilment of GxP requirements).
• To be a quality focal point/back-up for electronic document management system as well as the eQMS tool.

QUALIFICATIONS & REQUIRED SKILLS

• Technical University Degree (health, pharma, technical, chemical areas are advantage)
• Minimum 8 years of experience in pharma quality (IS, qualification, validation, corporate organizations are advantage)
• Knowledge of GxP regulations, process management, auditing
• English language in writing and speaking.
• Ability to learn / quick adaptability / analytical /organized / communicative.
• Ability to collaborate with transversal teams.