GxP Validation & Testing Systems Manager

Moderna; Województwo mazowieckie; On-site; PLN 120,000 - 180,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Family building benefits

Generous paid time off

Savings & investments

Location-specific perks

Job summary

Moderna is seeking a senior validator for its Digital landscape, applying CSA principles to validate GxP applications, data platforms, and infrastructure. You will lead and review validation deliverables, coordinate with Compliance, Quality, and Digital teams, and manage contractors to achieve quality and timely outcomes.

You will define and execute risk-based validation strategies, leverage AI and automation to accelerate delivery, and continuously improve validation methodologies while

Qualifications

• Bachelor’s degree in a related discipline with 6+ years of relevant experience or Master’s with 4+ years.
• Hands-on experience with GxP computerized systems, including validation, testing, digital quality, or compliance activities.
• Demonstrated experience with Computer Software Assurance (CSA) and risk-based assurance.
• Strong knowledge of regulatory requirements and guidance (21 CFR Part 11, EU Annex 11, GAMP 5).
• Experience developing, reviewing, or approving validation and testing deliverables (plans, risk assessments, test scripts, traceability, deviations).
• Experience with SaaS/cloud-based GxP applications and supplier documentation/testing evidence.
• Familiarity with SDLC, change/release management in regulated systems.
• Ability to lead cross-functional validation/testing activities and influence without authority.
• Excellent written and verbal communication translating regulatory needs into practical requirements.

Responsibilities

• Define validation requirements with stakeholders to enable timely delivery of GxP technology.
• Own validation, qualification, and testing activities for GxP applications, platforms, and infrastructure.
• Develop and execute risk-based validation strategies using CSA and regulatory requirements.
• Author and approve validation deliverables, including data integrity assessments and traceability.
• Lead planning and execution of testing with appropriate assurance for system use and risk.
• Support AI-enabled GxP applications using risk-based controls.
• Improve processes, templates, and tools for validation and testing readiness.

Skills

GxP validation

CSA

Risk-based testing

AI testing

Regulatory knowledge

Vendor management

Cross-functional work

SDLC

Communication

Education

Bachelor’s degree in Computer Science, Engineering, Life Sciences, Information Systems, or related discipline

Master’s degree

Tools

CSA frameworks

Traceability tools

Validation tools

Job description

Moderna is seeking a senior validator for its Digital landscape, applying CSA principles to validate GxP applications, data platforms, and infrastructure. You will lead and review validation deliverables, coordinate with Compliance, Quality, and Digital teams, and manage contractors to achieve quality and timely outcomes.

You will define and execute risk-based validation strategies, leverage AI and automation to accelerate delivery, and continuously improve validation methodologies while