Senior Quality & Compliance Lead — Computer System Validation

precisionmedicinegroup; United States; On-site; USD 120,000 - 165,000; Full time

Job summary

precisionmedicinegroup seeks a Quality & Compliance Manager, Computer System Validation, to oversee GxP computer system validation across the lifecycle from implementation to retirement. You will ensure data integrity, regulatory compliance, and readiness for inspections while driving continuous improvement across CRO and laboratory environments.

The role collaborates with Quality, IT, system owners, operational teams, and vendors to establish controls and promote scalable, risk-based practices

Qualifications

• Bachelor's degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant scientific or technical discipline.
• Demonstrated experience providing independent QA oversight of GxP computerized systems throughout the system lifecycle.
• Experience reviewing and approving computer system validation or assurance documentation.
• Working knowledge of regulatory requirements such as FDA 21 CFR Part 11 and ICH guidelines.

Responsibilities

• Provide independent, risk-based Quality Assurance oversight of GxP computerized systems throughout the system lifecycle.
• Review and approve validation and assurance deliverables with proper traceability.
• Ensure computerized systems are fit for intended use and compliant with regulatory requirements.
• Provide QA oversight for systems supporting clinical research and laboratory activities.
• Oversee ongoing validated state through changes, incidents, and decommissioning activities.
• Develop, maintain, and improve policies, procedures, templates, tools, and training for computer system validation.
• Prepare for sponsor audits, regulatory inspections, and internal audits.

Skills

Quality Assurance oversight

Risk-based thinking

Regulatory compliance knowledge

Education

Bachelor's degree in life sciences or related field

Tools

Validation documentation tools

Audit management systems

Job description

precisionmedicinegroup seeks a Quality & Compliance Manager, Computer System Validation, to oversee GxP computer system validation across the lifecycle from implementation to retirement. You will ensure data integrity, regulatory compliance, and readiness for inspections while driving continuous improvement across CRO and laboratory environments.

The role collaborates with Quality, IT, system owners, operational teams, and vendors to establish controls and promote scalable, risk-based practices