GxP QA & Computer System Validation Lead

Precision For Medicine; Houston (TX); Sur place; USD 92 000 - 120 000; Plein temps

Résumé du poste

Precision Medicine Group is seeking a Quality & Compliance Manager, Computer System Validation to oversee QA for GxP computerized systems across CRO and laboratory environments. You will partner with Quality, IT, system owners, and external providers to ensure data integrity and regulatory compliance from implementation through retirement.

The role drives risk-based assurance across clinical and laboratory operations, manages validation activities, and supports sponsor audits and inspections to

Qualifications

• Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant discipline.
• Minimum six years in Quality Assurance, computer system validation, or related regulated life sciences field.
• Experience providing independent QA oversight of GxP systems across lifecycle.
• Experience reviewing validation/assurance documentation (plans, requirements, traceability, evidence).
• Familiarity with FDA/EU regulatory expectations and data-integrity principles.

Responsabilités

• Provide independent QA oversight of GxP computer systems throughout lifecycle.
• Review and approve validation deliverables and traceability matrices.
• Ensure systems are fit for intended use, with data integrity and secure controls.
• Oversee clinical and laboratory software and interfaces within scope.
• Evaluate changes, incidents, deviations, CAPAs, and migrations for compliance.
• Support supplier qualification, audits, and regulatory inspections.
• Develop and improve validation policies, templates, and training.
• Prepare for sponsor audits and regulator inspections; ensure inspection readiness.
• Establish metrics for validation status and risks; drive continuous improvement.

Connaissances

QA oversight

GxP computerized systems

system lifecycle

risk-based assurance

regulatory compliance

Formation

Bachelor’s degree in life sciences or related field

6+ years in QA or computer system validation

Outils

LIMS

ELN

CDS

ICH GCP

Description du poste

Precision Medicine Group is seeking a Quality & Compliance Manager, Computer System Validation to oversee QA for GxP computerized systems across CRO and laboratory environments. You will partner with Quality, IT, system owners, and external providers to ensure data integrity and regulatory compliance from implementation through retirement.

The role drives risk-based assurance across clinical and laboratory operations, manages validation activities, and supports sponsor audits and inspections to