GxP Computer System Validation Lead

Pfm; United States; Remote; USD 92,000 - 120,000; Full time

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group in the United States seeks a Quality & Compliance Manager for Computer System Validation. You will oversee GxP systems from implementation to retirement, ensuring data integrity, compliance, and inspection readiness across CRO and lab environments.

You will lead risk-based validation, review deliverables, and coordinate audits with cross-functional teams, vendors, and regulators. A strong quality background and collaboration across IT and QA are essential.

Qualifications

• Independent QA oversight of GxP systems across lifecycle.
• Experience with validation plans, risk assessments and traceability.
• Knowledge of FDA/EU regulatory expectations and data integrity.

Responsibilities

• Provide risk-based QA oversight across system lifecycle.
• Review validation deliverables, plans, evidence, and deviations.
• Ensure data integrity and compliance with regulatory requirements.
• Oversee validation state for CTMS, ELN, LIMS and related tools.
• Support audits, inspections, and supplier/service provider oversight.

Skills

Quality Assurance

GxP

Risk-based validation

Software validation

Education

Bachelor’s degree in life sciences or related

Master’s degree preferred

Tools

LIMS

ELN

CDS

EDC

CTMS

eTMF

Job description

Precision Medicine Group in the United States seeks a Quality & Compliance Manager for Computer System Validation. You will oversee GxP systems from implementation to retirement, ensuring data integrity, compliance, and inspection readiness across CRO and lab environments.

You will lead risk-based validation, review deliverables, and coordinate audits with cross-functional teams, vendors, and regulators. A strong quality background and collaboration across IT and QA are essential.