IT Quality Assurance Manager 18600 Stockholms län, Sweden

Veritaz AB; Sweden; On-site; SEK 900,000 - 1,200,000; Full time

Job summary

Veritaz AB is seeking an experienced Quality Manager IT to lead IT compliance for computerized systems and infrastructure. You will review risk assessments, qualification and validation documents, and manage change controls and periodic reviews to ensure GMP/GxP conformity.

The role focuses on supporting CSV activities, collaborating with QA, IT, Validation, and business stakeholders, and driving quality improvements across IT systems with audit readiness in mind.

Qualifications

• Experience in IT Compliance within pharmaceutical, biotech, or similar GxP-regulated industries.
• Strong understanding of Computerized System Validation (CSV).
• Experience reviewing qualification and validation documentation.
• Knowledge of GMP, GxP, and pharmaceutical quality systems.
• Strong understanding of Data Integrity principles (ALCOA+).
• Experience with change control, risk assessments, and periodic reviews.
• Experience supporting QA and validation activities for computerized systems.
• Excellent communication and stakeholder management skills.
• Pragmatic, solution-oriented, and collaborative mindset.
• Flexible with a proactive approach to quality and compliance.

Responsibilities

• Ensure IT compliance for computerized systems and IT infrastructure.
• Review and approve risk assessments, qualification, and validation documentation.
• Review change controls, deviations, and periodic system reviews.
• Ensure compliance with GMP, GxP, SOPs, and internal quality requirements.
• Support Computerized System Validation (CSV) activities.
• Participate in IT compliance, qualification, and validation projects.
• Provide QA support for IT projects and system changes.
• Ensure data integrity principles are applied across IT systems.
• Maintain and update the inventory of computerized systems.
• Collaborate with QA, IT, Validation, Infrastructure, and Business stakeholders.
• Support continuous improvements in IT quality, security, availability, and compliance.
• Contribute to regulatory inspections and audit readiness.
• Review technical documentation to ensure regulatory compliance.
• Support quality activities throughout the system lifecycle.

Skills

IT compliance

CSV (Computerized System Validation)

GMP & GxP knowledge

Data integrity (ALCOA+)

Change control & risk assessments

Periodic system reviews

QA support for IT projects

Regulatory inspections & audit prep

Stakeholder management

Collaborative mindset

Job description

Assignment Description

We are looking for an experienced Quality Manager IT

What You Will Work On

• Ensure IT compliance for computerized systems and IT infrastructure
• Review and approve risk assessments, qualification, and validation documentation
• Review change controls, deviations, and periodic system reviews
• Ensure compliance with GMP, GxP, SOPs, and internal quality requirements
• Support Computerized System Validation (CSV) activities
• Participate in IT compliance, qualification, and validation projects
• Provide QA support for IT projects and system changes
• Ensure data integrity principles are applied across IT systems
• Maintain and update the inventory of computerized systems
• Collaborate with QA, IT, Validation, Infrastructure, and Business stakeholders
• Support continuous improvements in IT quality, security, availability, and compliance
• Contribute to regulatory inspections and audit readiness
• Review technical documentation to ensure regulatory compliance
• Support quality activities throughout the system lifecycle

What You Bring

• Experience working in IT Compliance within the pharmaceutical, biotech, or other GxP-regulated industries
• Strong understanding of Computerized System Validation (CSV)
• Experience reviewing qualification and validation documentation
• Knowledge of GMP, GxP, and pharmaceutical quality systems
• Strong understanding of Data Integrity principles (ALCOA+)
• Experience with change control, risk assessments, and periodic reviews
• Experience supporting QA and validation activities for computerized systems
• Excellent communication and stakeholder management skills
• Pragmatic, solution-oriented, and collaborative mindset
• Flexible with a proactive approach to quality and compliance