IT Quality Systems and CSV Specialist

Remotedxb; Dubai; On-site; AED 300,000 - 540,000; Full time

Benefits offered by this job

Permanent Contract

Salary package

Ticket restaurant

Flexible benefits

Gym discounts

Learning & Development

Job summary

Remotedxb is seeking an IT Quality & Compliance professional to oversee global IT quality activities, ensure regulatory compliance and govern validation of IT infrastructure and computerized systems.

The role requires strong communication, analytical thinking and the ability to build consensus with stakeholders. Experience with GxP, ITIL and GAMP is essential, with responsibility for audits and training.

Qualifications

• Master's degree in computer science, biotechnology or related field.
• Experience with quality management systems (e.g. GAMP) and IT standards (e.g. ITIL).
• In-depth knowledge of regulatory environment (GxP, audits) and IT.

Responsibilities

• Ensure IT Quality & Compliance activities across the global IT function.
• Support compliance with regulatory requirements and corporate policies within IT.
• Provide Quality & Compliance oversight for IT infrastructure qualification and computer system validation.
• Coordinate and support internal and external IT audits and inspections.
• Deliver GxP and non-GxP compliance training and drive awareness among IT personnel.

Skills

Excellent communication

Analytical thinking

Consensus building

Influence decisions

Education

Master's degree in computer science/biotech/related field

Tools

ITIL

GAMP

Job description

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