IT QA Lead Expert - Quality & Manufacturing Systems
Zagreb, Croatia, 10000
Who we are
The opportunity
The primary purpose of this role within the Global Operations unit of the Global IT Quality and Compliance (IT Q&C) department is to provide expert-level support for validation and compliance activities related to computerized systems, with a focus on Quality Control (QC) systems (e.g., LIMS, Empower) and Electronic Document Management Systems (EDMS). The role involves working alongside IT project teams to guide and oversee validation efforts throughout the System Development Lifecycle (SDLC), ensuring alignment with applicable regulatory requirements, internal standards, and procedures.
How you’ll spend your day
The role includes the following responsibilities to support services offered by Global Operations:
- Provide validation support for IT projects by reviewing and approving validation deliverables from a Quality perspective, including specifications, test plans, test results, and change controls.
- Support system lifecycle activities by creating, reviewing, and maintaining validation documentation in compliance with GxP and internal standards.
- Ensure data integrity (ALCOA+) is embedded in system design, implementation, and operation.
- Collaborate with IT, Quality, and Business stakeholders to ensure alignment on validation and compliance expectations.
- Support complex system implementations and upgrades, applying a risk-based approach to validation and compliance.
- Contribute to the development and maintenance of validation procedures, templates, and strategic documentation.
- Provide informal guidance and training to project teams and stakeholders on validation practices, regulatory expectations, and internal policies.
- Actively contribute to the continuous improvement and knowledge sharing within the IT Q&C team and across the organization.
The role also includes the following responsibilities to support services offered by the IT Q&C department:
- Support internal and external audits (regulatory, customer, supplier) and ensure audit readiness.
- Contribute to the global supplier qualification process by reviewing validation and compliance documentation.
- Support the management and maintenance of procedures, guidelines, and training materials.
- Assist in infrastructure qualification and inventory management activities.
- Participate in IT Q&C process improvement initiatives.
Your experience and qualifications
- Bachelor’s or Master’s degree in Information Technology, Life Sciences, or a related field.
- Minimum of 3 years of professional experience in Computer System Validation (CSV) or SDLC activities in a GxP-regulated environment.
- Experience in IT system implementation, particularly in QC and EDMS domains.
- In-depth knowledge of GxP compliance requirements from EMA, FDA, and other relevant regulatory bodies.
- Strong understanding of risk-based validation and compliance approaches.
- Proven experience in CSV within regulated environments.
- High attention to detail and results-oriented mindset.
- Excellent command of English (written and spoken).
- Strong interpersonal, communication, and presentation skills.
- Ability to work effectively in a global, cross-functional team environment.
Already Working @TEVA?
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