GxP Compliance QA Lead — Systems & CSV/DI

Ledgent Technology; Alameda (CA); On-site; USD 80,000 - 96,000; Full time

Job summary

Ledgent Technology seeks a Compliance QA Manager - Systems to oversee CSV/DI processes and ensure GxP compliance. The role focuses on validating applications, managing access, and supporting QA activities in a regulated environment.

Onsite in Alameda, CA, the position requires 5+ years in validated systems, strong documentation, and cross-functional collaboration to drive quality improvements and audits readiness.

Qualifications

• 5+ years of experience with validated applications in a pharmaceutical or regulated environment.
• Experience implementing GxP computerized systems and maintaining validated state.
• Strong communication and cross-functional collaboration skills.

Responsibilities

• Oversight of CSV/DI programs and QMS activities to ensure compliance.
• Manage system access, permissions and documentation across tools.
• Prepare and execute validation activities, UAT and PQ where applicable.
• Generate metrics and support audits/inspections.

Skills

CSV/DI Knowledge

GxP Regulation

Communication Skills

Tools

Veeva Platform

Job description

Ledgent Technology seeks a Compliance QA Manager - Systems to oversee CSV/DI processes and ensure GxP compliance. The role focuses on validating applications, managing access, and supporting QA activities in a regulated environment.

Onsite in Alameda, CA, the position requires 5+ years in validated systems, strong documentation, and cross-functional collaboration to drive quality improvements and audits readiness.