Remote QA Lead - Computer System Validation & Compliance

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

Benefits offered by this job

Discretionary annual bonus

Health insurance

Retirement savings benefits

Parental leave

PTO

Job summary

Precision Medicine Group, LLC. is seeking a Quality & Compliance Manager, Computer System Validation to oversee the quality assurance of GxP computerized systems across their lifecycle in CRO and laboratory settings.

You will partner with Quality, IT, system owners, and external providers to ensure systems are fit for intended use, compliant, and audit-ready from implementation through retirement. A discretionary annual bonus and comprehensive benefits apply.

Qualifications

• Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or related field.
• Minimum six years in QA, computer system validation, or related regulated life sciences role.
• Experience providing independent QA oversight of GxP systems across lifecycle.
• Experience reviewing validation or assurance documentation (validation plans, risk assessments, test plans).
• Knowledge of FDA 21 CFR Part 11, EU Annex 11, ICH GCP/GLP, data integrity.
• Experience with CRO/clinical research or laboratory systems (EDC, LIMS, ELN, CDS).

Responsibilities

• Provide independent QA oversight of GxP computerized systems across lifecycle.
• Review validation plans, requirements, traceability, tests, deviations, and release-readiness docs.
• Ensure systems meet data integrity, electronic records, signatures, audit trails, and access controls.
• Oversee QA for clinical and laboratory platforms like EDC, LIMS, ELN, CDS.
• Coordinate responses to observations and support sponsor audits and inspections.
• Develop policies, templates, and training for computer system validation.
• Establish metrics on validation status, deviations, CAPAs, and supplier performance.

Skills

Quality Assurance

GxP

CS Validation

Regulatory Compliance

Risk-Based QA

Clinical Systems

Education

Bachelor's degree in life sciences or related field

Master's degree preferred

Tools

LIMS

ELN

EDC

CDS

Audit management software

Job description

Precision Medicine Group, LLC. is seeking a Quality & Compliance Manager, Computer System Validation to oversee the quality assurance of GxP computerized systems across their lifecycle in CRO and laboratory settings.

You will partner with Quality, IT, system owners, and external providers to ensure systems are fit for intended use, compliant, and audit-ready from implementation through retirement. A discretionary annual bonus and comprehensive benefits apply.