Quality & Compliance Lead - Computer System Validation

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

Benefits offered by this job

Discretionary annual bonus

Health coverage

Retirement savings

Life and disability insurance

Parental leave

Paid sick leave

Paid vacation

Job summary

precisionmedicinegroup seeks an experienced QA professional to provide independent, risk-based quality oversight for computerized systems in regulated clinical research and lab operations. You will guide validation and assurance across systems' lifecycles, ensuring fitness for use, reliable records, and audit-ready documentation.

Responsibilities include reviewing risk assessments, validation plans, and release docs; ensuring data integrity, electronic records and signatures, and proper access

Qualifications

• Experience ensuring GxP systems live through risk-based validation and QA oversight.
• Ability to review validation documents, tests, and release readiness.
• Experience evaluating data integrity risks and controls across systems.
• Collaborates with Quality, IT, operations and vendors to define responsibilities.

Responsibilities

• Review risk assessments and validation plans.
• Assess controls supporting data integrity, e-signatures, audit trails, and retention.
• Oversee system changes, migrations, and retirements; escalate risks.
• Coordinate with Quality, IT, security, labs and service providers to establish controls.
• Maintain procedures and templates for risk-based validation and software assurance.
• Support audits and inspections; keep records retrievable and compliant.

Skills

QA oversight

Risk assessment

Computer System Validation

Data integrity

Audit readiness

Cross-functional teamwork

Education

Bachelor's degree in life sciences/engineering

Job description

precisionmedicinegroup seeks an experienced QA professional to provide independent, risk-based quality oversight for computerized systems in regulated clinical research and lab operations. You will guide validation and assurance across systems' lifecycles, ensuring fitness for use, reliable records, and audit-ready documentation.

Responsibilities include reviewing risk assessments, validation plans, and release docs; ensuring data integrity, electronic records and signatures, and proper access