Remote Quality & Compliance Lead — Computer System Validation

Precision Medicine Group; Northern (KY); Remote; USD 92,000 - 120,000; Full time

Benefits offered by this job

Health insurance

Retirement savings

Life insurance

Disability benefits

Parental leave

Paid time off

Job summary

Precision Medicine Group is seeking a Quality & Compliance Manager, Computer System Validation, to oversee QA for GxP computerized systems across CRO and laboratory operations, partnering with Quality, IT, and vendors to ensure data integrity and inspection readiness from implementation through retirement.

The role leads risk-based validation activities, approves validation deliverables, supports sponsor audits, and develops policies and training to sustain compliant systems across globally

Qualifications

• Bachelor's degree in life sciences, computer science, information systems, engineering, healthcare, or related field.
• Six+ years in Quality Assurance, computer system validation, or related regulated discipline within life sciences.
• Experience providing independent QA oversight of GxP systems across the lifecycle.
• Experience reviewing validation and assurance documentation (plans, requirements, traceability, reports).
• Knowledge of FDA electronic records/signatures, EU Annex 11, ICH GCP/GLP/GCLP/GMP.
• Experience with CRO, clinical research, or laboratory GxP platforms (EDC, CTMS, LIMS, ELN).
• Familiarity with risk-based validation and supplier/vendor audits.

Responsibilities

• Provide independent QA oversight of GxP computerized systems lifecycle from assessment to retirement.
• Review and approve validation/assurance deliverables and ensure traceability.
• Ensure data integrity and regulatory compliance, including electronic records and access controls.
• Provide QA oversight for clinical and laboratory platforms and related data repositories.
• Evaluate changes, incidents, deviations, CAPAs, migrations, and decommissioning activities.
• Develop and improve validation policies, templates, tools, and training.
• Prepare for sponsor audits, regulatory inspections, and internal audits; coordinate responses.

Skills

Quality Assurance

GxP

Computer System Validation

Risk-based approach

Regulatory compliance

Audit readiness

Cross-functional collaboration

Education

Bachelor's degree

Master's degree

Tools

LIMS

ELN

CDS

EDC

Job description

Precision Medicine Group is seeking a Quality & Compliance Manager, Computer System Validation, to oversee QA for GxP computerized systems across CRO and laboratory operations, partnering with Quality, IT, and vendors to ensure data integrity and inspection readiness from implementation through retirement.

The role leads risk-based validation activities, approves validation deliverables, supports sponsor audits, and develops policies and training to sustain compliant systems across globally