Hands-on experience with SaaS validation platforms like Veeva
Ability to operate strategically and at an execution level
Strong leadership capabilities in managing a team
Responsibilities
Lead and enhance the Validation / CSV program
Assess gaps in existing validation processes
Prepare for FDA audits and support inspection readiness
Oversee validation activities for various enterprise systems
Manage a small team executing CSV activities
Ensure effective validation and compliance at all levels
Benefits
Opportunity to lead a significant compliance initiative
Engagement with multiple enterprise systems
Support for professional growth and development
Dynamic work environment focused on compliance
Exposure to cutting-edge validation technologies
Full Job Description
Job Summary:
Responsible for leading and maturing the Validation / Computer System Validation (CSV) program, ensuring compliance with GxP and FDA requirements.
The role focuses on driving validation strategy, closing compliance gaps, supporting audit readiness, and overseeing validation activities across multiple enterprise systems while leading a team.
Roles & Responsibilities:
Lead and enhance the Validation / CSV program.
Assess gaps in current validation processes and drive remediation roadmap.
Prepare for FDA audits and support inspection readiness activities.
Oversee validation activities across systems including Veeva, TMF, Argus, and Serialization platforms.
Lead and manage a small team executing CSV activities.
Operate at both strategic and execution levels to ensure effective validation and compliance.
Experience:
12+ years of experience in GxP CSV / Validation.
Strong experience in FDA audit support and inspection readiness.
Hands-on experience with SaaS validation platforms (e.g., Veeva).
Ability to work at both strategic and execution levels.
