Manager, Computer System Validation (CSV), QA - Remote

Overview

The Manager, Computer System Validation (CSV), QA will provide quality oversight of the computer system validation lifecycle from design and implementation to retirement, ensuring compliance of GxP applications.

In Short

• Provide QA oversight of the GxP computer system validation lifecycle.
• Review and approve IT change control and validation deliverables.
• Evaluate risk assessments and determine the impact of changes.
• Participate in periodic system reviews and release management activities.
• Collaborate with IT and stakeholders to establish system validation requirements.
• Drive continuous improvement initiatives for QMS and validated GxP systems.
• Support regulatory inspections and audits.
• Collaborate to optimize workflows and system usability.
• Review and approve GxP-computer system SOPs.
• Serve as QA CSV subject matter expert.

Requirements

• Bachelor’s or Master’s degree in software or related field.
• 8+ years of experience in quality systems in pharma or biotech.
• Excellent attention to detail and strong organizational skills.
• Effective communication skills.
• Expertise in GxP computerized system validation.
• Strong knowledge of regulatory requirements.
• Hands-on experience with validated platforms (Veeva, SAP, etc.).
• Experience developing GxP SOPs.
• Ability to work independently and collaboratively.
• Familiarity with risk-based validation methodologies.

Benefits

• Market leading compensation.
• 401K with employer match.
• Comprehensive health care.
• Hybrid work model.
• Unlimited flexible paid time off.
• Paid parental leave.
• Skill development opportunities.
• Career pathing through feedback and education.
• Financial rewards for strong performance.