Regulatory Validation Lead - GxP, SaaS & AI

Planet Pharma; Raleigh (NC); On-site; USD 69,000 - 88,000; Full time

Job summary

Planet Pharma seeks a Validation Specialist, Regulatory to implement GxP computerized systems within the R&D IT department in Raleigh, NC. The role emphasizes CSA validation of SaaS applications and AI models, and requires familiarity with US and EU regulations.

The position includes scientific writing, validation deliverables, and change management to ensure compliant system validation and ongoing system integrity.

Qualifications

• Bachelor’s Degree in Computer Science or information systems.
• 3–5 years in a position of equal scope and responsibility.
• Experience in the pharmaceutical or medical device industry.

Responsibilities

• Implement GxP computerized systems for the R&D IT department.
• Write validation documents, change controls, validation plans, and training materials.
• Lead meetings, coordinate with stakeholders, and drive user adoption and change management.
• Maintain the validated state of applications in accordance with policies and procedures.

Skills

CSA principles

GAMP 5

Regulatory knowledge

Stakeholder management

Education

Bachelor’s Degree in Computer Science / Information Systems

Tools

Electronic validation apps

Job description

Planet Pharma seeks a Validation Specialist, Regulatory to implement GxP computerized systems within the R&D IT department in Raleigh, NC. The role emphasizes CSA validation of SaaS applications and AI models, and requires familiarity with US and EU regulations.

The position includes scientific writing, validation deliverables, and change management to ensure compliant system validation and ongoing system integrity.