Job Description

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 Comm Ops Quality Specialist operates within Commercial Operations Quality, supporting clusters, affiliates, and direct export markets to ensure the implementation of a risk-based Quality Management System (QMS) and adherence to Corporate SOPs and regulatory requirements.

The role contributes to the development, harmonization, and implementation of Commercial Quality processes, while providing operational QA support across affiliates, representative offices, export markets, and commercial operations. It ensures effective cluster–affiliate interface management and drives consistent application of the risk-based QMS.

KEY RESPONSIBILITIES AND ACTIVITIES

• Support the Head of Corporate Quality Commercial Operations in establishing and maintaining a harmonized, risk-based Quality Management System (QMS) across clusters, affiliates, and export countries.

• Drive harmonisation, development, simplification, and implementation of Corporate SOPs, ensuring clear and consistent requirements applicable across all entities.

• Single point of contact for affiliates to corporate functions and vice versa.

• Ensure effective implementation and consistent application of Corporate SOPs across clusters, affiliates, and export countries, including within the EDMS environment.
• Support clusters in process harmonization and the sharing of best practices to drive consistency and efficiency.
• Support coordination of activities within the Commercial Quality team, including Comm Ops QA Specialists and affiliate, export, and representative office support roles.

• Support onboarding new team members and facilitate knowledge transfer.

• Act as the central quality contact for assigned clusters, affiliates, representative offices and direct export markets, ensuring effective coordination of quality activities across the network.

• Managed end-to-end complaints and deviation processes, supporting affiliates in case handling, ensuring accurate recording in the Quality Forward system, and coordinating distribution to the appropriate manufacturing sites or ESO. Ensured timely communication of investigation outcomes and responses back to target markets.
• Initiate and manage Change Controls and Risk Management activities in alignment with ICH Q9 principles, ensuring appropriate assessment, prioritization, and cross-functional coordination across clusters and affiliates.
• Support Health Authorities requests, such as documentation, requests, regulatory samples and all requests
• Establish and maintain an effective communication network between Corporate Quality, clusters, affiliates, and direct export markets to ensure timely exchange of quality-related information and alignment of expectations.
• Provide training, coaching, and guidance to affiliates and internal stakeholders on Corporate Quality System requirements, with a focus on newly established or developing markets, new hires, and role transitions, as assigned by the Line Manager.
• Participate in Corporate Quality meetings and cross-functional forums to represent cluster and affiliate quality activities and provide operational input.
• Support the development and monitoring of Key Performance Indicators (KPIs). These KPIs should provide insights into the effectiveness of quality processes for the Commercial entities
• Perform additional tasks as assigned by the Line Manager in alignment with the scope of Corporate Quality Commercial Operations and evolving business needs.

OTHER RESPONSIBILITIES

QUALITY

• Ensure full adherence to GxP principles and internal Quality standards
• Maintain compliance with applicable regulatory requirements

HSE

• Adheres to the principles communicated within the ESMS Policy of Zentiva detailed in the internal rules of the Company for the purpose of observing the rules of the Health & Safety at Work and the Environmental & Safety Management System.

PHARMACOVIGILANCE

• All employees are obliged to report any suspicion to adverse events of medicinal products, any adverse events concerning use of a medical device and any other safety information about medicinal products or medical devices in line with relevant internal regulations.

COMPLIANCE

• The employee will comply with all internal policies and rules of the Company. The employee will make her/himself acquainted with Code of Ethics and will comply with the principles stated therein and in all related policies and other internal documents.

PHARMACOVIGILANCE

• Adheres to the principles of ESG detailed in the Sustainability Strategy and its 3 pillars of People, Partners, and the Planet.

QUALIFICATIONS & REQUIRED SKILLS

• University degree in Pharmacy, Chemistry, Biology, or relevant Life Science
• Knowledge of pharmaceutical GxP regulations and Quality system
• Experience in transformation, working in a dynamic environment.
• Collaborative and team-oriented
• Very good communication skills, and a customer-oriented approach.
• Flexibility and ability to manage competing priorities.
• Sense of urgency, high autonomy & stress resistance, agile personality
• Proven hands-on attitude, be flexible and adaptable, open minded.
• Open minded, positive, and energetic person
• Good Microsoft applications knowledge and computer skills
• Advanced knowledge of English