Quality Manager – GxP

Short company description

We’re expanding in Romania with Spyrosoft, a trusted name in the industry. This partnership strengthens our presence and creates new opportunities for IT professionals.
Together, we are building an integrated IT team focused on infrastructure, cybersecurity, and SAP services from Timisoara. We’re offering a collaborative, growth-oriented environment where professionals can develop, innovate, and make an impact.

Manage Now is a fast-growing company with a strong foundation. Headquartered in Germany and employing around 1,600 people, we specialise in digital workspace, hybrid infrastructure, and SAP-centred business applications. Our company combines the agility of a startup with the expertise and reliability of our legacy.

Requirements

Requirements:
- IT infrastructure
- GxP
- Quality Management
- IT Systems/ Services
- IOQ
- GxP Audits
- CAPA Management
- CSV
- ISO 9001
- ISO 20000
- ISO 27001
- ISO 13485
- University Degree in informatics, business engineering or equivalent.
- Strong technical background in IT infrastructure.
- Expert in Computer System Validation (CSV)
- 3-5 years professional experience, working for IT Service Provider
- Practical experience with validation / qualification of GxP-regulated IT Systems and its infrastructure, ideally in QA functions
- Familiar with current GxP regulations in CSV, ideally qualification of IT infrastructure
- Familiar with CSV applications
- Knowledge in ISO 9001and ISO 20000
- Ideally knowledge in ISO 27001 and ISO 13485
- High customer orientation
- Analytical thinking and structured working methods
- Language Skills: Fluency in English (spoken and written) is mandatory; German language skills are an advantage.

Responsibilities

Main responsibilities:
- Single Point of Contact for all local GxP-related aspects in collaboration within the Quality Management team.
- Execution of local GxP trainings for staff working on GxP-regulated IT Systems / Services.
- Ensures that all staff working on GxP-regulated IT Systems / Services are trained adequately before execution.
- Review of change requests focusing on risk assessments related to GxP-requirements including definition of required documentation.
- Consulting of local staff regarding GxP-regulated processes (change management, infrastructure qualification activities, etc.) and tool-based processing.
- Collaboration with QM team to ensure local implementation of GxP-related processes.
- Review of validation and qualification documentation processed locally (e.g. IOQ test protocols, screenshots) from quality perspective.
- Managing GxP relevant documentation (e.g. training records, process documents, templates).
- Supporting internal and external GxP-Audits as well as CAPA Management.

Other info

The Quality Manager GxP acts as IT Quality Assurance to ensure compliance to the before mentioned regulatory aspects locally.

The Quality Manager actively works together with the Governance QM-Team to make sure the GxP -relevant processes are implemented, trained and followed locally.

The person acts as SPOC and IT Subject Matter expert for all local staff regarding GxP-related activities.