GxP Systems & Validation Lead

Moderna Therapeutics; Warszawa; On-site; PLN 180,000 - 260,000; Full time

Benefits offered by this job

Healthcare benefits

Well-being resources

Family building benefits

Paid time off

Investment options

Location-specific perks

Job summary

Moderna Therapeutics in Warsaw seeks a senior validation lead to define validation requirements, deliver testing of GxP applications, and drive risk-based strategies across digital platforms and infrastructure. You will author, review, and approve validation deliverables, including data integrity assessments and test scripts, while partnering with Quality, Digital/IT, and vendors.

The role emphasizes CSA principles, supplier evidence, and automation to improve efficiency without compromising GxP

Qualifications

• 6+ years in pharmaceutical/regulated validation.
• Experience with CSA, risk-based testing, and supplier evidence.
• Knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5 and data integrity.

Responsibilities

• Define validation requirements and enable timely delivery of GxP technology.
• Own validation, qualification, and testing across applications, platforms, data solutions, and infrastructure.
• Lead planning, execution, and documentation of testing; ensure appropriate level of assurance for system use.

Skills

GxP validation

CSA knowledge

Regulatory compliance

Leadership

Testing strategy

Education

Bachelor's or higher in STEM

Tools

CSA tools

Job description

Moderna Therapeutics in Warsaw seeks a senior validation lead to define validation requirements, deliver testing of GxP applications, and drive risk-based strategies across digital platforms and infrastructure. You will author, review, and approve validation deliverables, including data integrity assessments and test scripts, while partnering with Quality, Digital/IT, and vendors.

The role emphasizes CSA principles, supplier evidence, and automation to improve efficiency without compromising GxP