Computer System Validation Lead

Role-Computer System Validation Lead

Location-Boston, MA/hybrid, 3 days a week

Responsibilities:
Lead computer system validation activities to ensure GxP regulated systems are fit for intended use and compliant with regulatory expectations.
Define and apply risk-based validation and testing strategies across system life cycle.
Ensure validation is effectively integrated with SDLC and delivery models while maintaining compliance
Support data integrity, audit readiness and ongoing compliance across regulated systems
Lead validation workstream within projects, ensuring timely delivery, quality outcomes and stakeholder alignment.
Design validation documentation, traceability matrix and oversee change management for validated systems.

Qualifications:
Strong grounding in CSV, GAMP, SDLC and agile delivery models
Practical experience with computer system assurance, risk based validation and testing methodologies as per ICH Q9.
Ability to translate regulatory expectations into pragmatic, scalable validation approaches.
Demonstrating technical capabilities and professional knowledge of validating AI models.
Solid understanding of GxP regulations including 21 CFR Part 11, Annex 11, and data integrity guidance.
Effectively working on teams with diverse skills and backgrounds.
Clear, structured communication and strong documentation skills.