IT Quality Systems and CSV Specialist

Responsibilities

• Ensure IT Quality & Compliance activities are effectively implemented and monitored across the global IT function
• Support compliance with applicable regulatory requirements and corporate policies within the IT environment
• Provide Quality & Compliance oversight for IT infrastructure qualification and computer system validation activities
• Review and approve key SLC deliverables, including change controls, risk assessments, testing documentation, periodic reviews, and exception management
• Ensure compliance with CSV, electronic records, electronic signatures, and data integrity requirements
• Implement and monitor IT quality processes, including support during self-inspections
• Collaborate with global Quality and Compliance teams to address business quality and compliance needs
• Promote a culture of quality and compliance across the IT organization
• Deliver GxP and non-GxP compliance training and drive awareness among IT personnel
• Monitor adherence to corporate IT policies, procedures, SOPs, and work instructions
• Coordinate and support internal and external IT audits and inspections
• Conduct IT quality assessments and self-inspections, and monitor the effectiveness of CAPA actions
• Provide proactive quality and compliance guidance to support validation and qualification activities

Requirements

• Fluent in written and spoken English
• Master's degree in computer science, biotechnology or related field
• Several years of experience with quality management systems (e.g. GAMP) and IT standards (e.g. ITIL)
• In-depth knowledge of the regulatory environment (e.g. GxP, audits) and information technology
• In-depth knowledge of GxP-relevant IT processes and their support by computerized systems
• Excellent communication skills, analytical thinking and the ability to work in a spirit of partnership
• Ability to build consensus and influence decisions

Benefits

• Permanent Contract
• Salary package based on profile
• Ticket restaurant (if office attendance occurs)
• Flexible Retribution Program (medical insurance, public transport, childcare)
• Gym network discounts (Wellhub)
• Learning & Development opportunities