GxP Validation Lead - SaaS, AI & CSA (Hybrid)

Alliance of Professionals & Consultants, Inc.; Raleigh (NC); Hybrid; USD 76,000 - 90,000; Part time

Job summary

Alliance of Professionals & Consultants, Inc. is seeking a Validation Specialist to implement GxP computerized systems for R&D IT. The role requires CSA experience, knowledge of US/EU regulations, and validation of SaaS applications and AI models.

Hybrid role based in Raleigh, NC with 3 days in office. Responsibilities include writing validation documentation, leading stakeholder meetings, and ensuring continued compliance and state of validation across applications.

Qualifications

• GAMP 5 principles and regulatory frameworks (US/EU)
• Experience with CSA and regulatory software assurance
• Understanding of GxP computerized systems validation
• Ability to lead meetings and coordinate with stakeholders

Responsibilities

• Develop and implement validation strategy for GxP systems
• Create validation deliverables: plans, IOUs, changes controls, testing docs
• Lead project activities, train users, drive change management
• Maintain validated state of applications per policies and procedures

Skills

GAMP 5 principles

CSA principles

Regulatory knowledge

GxP software

Education

Bachelor’s Degree in Computer Science / Information Systems

Job description

Alliance of Professionals & Consultants, Inc. is seeking a Validation Specialist to implement GxP computerized systems for R&D IT. The role requires CSA experience, knowledge of US/EU regulations, and validation of SaaS applications and AI models.

Hybrid role based in Raleigh, NC with 3 days in office. Responsibilities include writing validation documentation, leading stakeholder meetings, and ensuring continued compliance and state of validation across applications.