12+ years of experience in GxP Computer System Validation (CSV) or Validation.
Strong experience in supporting FDA audits and ensuring inspection readiness.
Hands-on experience with SaaS validation platforms, particularly Veeva.
Ability to operate effectively at both strategic and execution levels.
Proven leadership skills in managing teams executing validation activities.
Responsibilities
Lead and enhance the Validation / CSV program.
Assess current validation processes to identify and remediate compliance gaps.
Prepare for FDA audits and support inspection readiness activities.
Oversee validation activities across systems such as Veeva, TMF, Argus, and Serialization platforms.
Lead and manage a small team executing CSV activities.
Drive strategic and execution initiatives to ensure validation compliance.
Benefits
Opportunity to lead and shape the Validation/CSV program.
Engagement with high-profile systems in the pharmaceutical industry.
Exposure to FDA audit processes and compliance standards.
Development and leadership opportunities in a growing team.
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.
