Quality & Compliance Manager, Computer System Validation

📋 Description

• Provide independent, risk-based Quality Assurance oversight of GxP computerized systems throughout
• Review and approve applicable validation and assurance deliverables, including system risk
• Ensure computerized systems are fit for intended use, maintain data integrity, and comply with
• Provide QA oversight for computerized systems supporting clinical research and laboratory
• Oversee the ongoing validated state of computerized systems by evaluating changes, incidents
• Support the qualification and ongoing oversight of software, cloud, data, and computerized-system

🎯 Requirements

• Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare
• A minimum of six years of progressively responsible experience in Quality Assurance, computer
• Demonstrated experience providing independent QA oversight of GxP computerized systems throughout
• Experience reviewing and approving computer system validation or assurance documentation, such as
• Working knowledge of applicable regulatory requirements and industry expectations, including FDA
• Experience supporting computerized systems used in CRO, clinical research, or laboratory

🎁 Benefits

• Discretionary annual bonus
• Health insurance
• Retirement savings benefits
• Life insurance
• Disability benefits
• Parental leave