IT QA & CSV Manager

The company seeks an IT QA & CSV Manager in Solothurn to oversee software quality, ensure regulatory compliance, and manage computer system validation within the medical industry.

This position sits within the corporate IT department with a primary focus on maintaining high software quality standards. The role ensures that all computer systems adhere to legal requirements and internal protocols, safeguarding operational reliability and compliance.

Responsibilities

• Verify that software applications and IT infrastructure function correctly and satisfy established quality benchmarks.
• Guarantee that computer systems align with applicable laws, as well as internal and external regulatory mandates.
• Detect potential risks associated with IT systems and develop strategies to reduce or eliminate these threats.
• Draft, update, review, and authorize documentation related to the validation lifecycle.
• Plan and supervise testing activities to confirm that systems operate reliably and meet performance expectations.
• Liaise with regulatory bodies, auditors, clients, and vendors regarding CSV and IT quality assurance matters.
• Perform computer system validations in accordance with GxP and GAMP guidelines to ensure process reliability.
• Drive ongoing enhancements to IT services and CSV workflows based on information security standards.

Requirements

• A university degree in a scientific or technical discipline.
• Formal training in Quality Assurance and Computer Validation Systems.
• Professional experience within the medical sector.
• Familiarity with Q systems and IT standards, including ISO 27001 and ISO 80002-2.
• Fluency in both German (C1 level or higher) and English.