IT Quality Systems and CSV Specialist

This is a fully remote position, open to applicants in Spain, +1 more country.

📋 Description

• Ensure effective implementation and monitoring of IT Quality & Compliance activities throughout the global IT function.

• Assist in maintaining compliance with relevant regulatory requirements and corporate policies within the IT landscape.

• Provide oversight for Quality & Compliance related to IT infrastructure qualification and computer system validation efforts.

• Review and authorize key Software Lifecycle (SLC) deliverables, including change controls, risk assessments, testing documentation, periodic reviews, and exception management.

• Ensure adherence to CSV, electronic records, electronic signatures, and data integrity standards.

• Implement and oversee IT quality processes, including support during self-inspections.

• Work collaboratively with global Quality and Compliance teams to meet business quality and compliance requirements.

• Foster a culture of quality and compliance within the IT organization.

• Provide GxP and non-GxP compliance training and raise awareness among IT staff.

• Monitor compliance with corporate IT policies, procedures, SOPs, and work instructions.

• Coordinate and facilitate internal and external IT audits and inspections.

• Conduct IT quality evaluations and self-inspections, monitoring the effectiveness of Corrective and Preventive Actions (CAPA).

• Offer proactive quality and compliance advice to support validation and qualification efforts.

⛳️ Requirements

• Proficient in both written and spoken English.

• Master's degree in computer science, biotechnology, or a related discipline.

• Several years of experience with quality management systems (e.g., GAMP) and IT standards (e.g., ITIL).

• Comprehensive understanding of the regulatory landscape (e.g., GxP, audits) and information technology.

• Extensive knowledge of GxP-relevant IT processes and their support through computerized systems.

• Strong communication abilities, analytical thinking, and a collaborative mindset.

• Capability to build consensus and influence decision-making.

🏝️ Benefits

• Salary package aligned with your profile, which will be discussed during our initial conversation.

• Permanent contract.

• Lunch vouchers provided for office attendance.

• Flexible Retribution Program, including medical insurance, public transport tickets, and childcare vouchers.

• Discounts available on a gym network (Wellhub).

• Opportunities for Learning & Development.

• Our aim is to ensure your well-being in every aspect!