Description

You will own the design, validation, and lifecycle management of GxP applications.

Responsibilities

• Author validation deliverables, including Validation/Compliance Plans, Reports, RTMs, Data Flow Maps, and Change Controls.
• Develop validation strategy for assigned projects.
• Provide audit support and manage Application Lifecycle Management tasks.
• Oversee and manage periodic system checks.
• Guide cross-functional teams and mentor junior staff.

Required Skills

• 10+ years of experience in Computer System Validation (CSV), Quality Management, or Business Analysis within a GxP application area.
• Deep understanding of Good Clinical Practices (GCP) and FDA 21 CFR Part 11 requirements.
• Proficiency with validation tracking tools such as JIRA, qTest, and ServiceNow (SNOW).
• Experience working with both Agile and Waterfall software development methodologies.
• Ability to perform risk identification and mitigation in regulated environments.
• Strong aptitude for analytical problem-solving.
• Skilled in project planning, execution, and minimizing rework.
• Clear written and verbal communication for technical documentation.

Key Skills

Education

Any Graduate