Quality & Compliance Manager, 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

Role overview

Provide independent, risk-based quality oversight for computerized systems used in regulated clinical research and laboratory operations. The manager guides validation and assurance across each system’s lifecycle, helping ensure systems are fit for intended use, records remain reliable, and documentation is ready for audits and inspections.

Responsibilities

• Review and approve risk assessments, validation plans, requirements, traceability records, test evidence, deviations, summary reports, and release documentation.
• Assess whether systems and their controls support data integrity, electronic records and signatures, audit trails, access management, backups, archiving, and retention.
• Oversee system changes, incidents, corrective actions, upgrades, data migrations, periodic reviews, and retirement activities; escalates risks and track remediation.
• Coordinate with Quality, IT, security, clinical and laboratory teams, system owners, and service providers to establish appropriate controls and clear responsibilities.
• Maintain and improve procedures, templates, tools, and training for risk-based validation and software assurance.
• Support audits and inspections, keep records complete and retrievable, and track performance and compliance trends to guide improvements.

Requirements

• Bachelor’s degree in a relevant life sciences, technical, healthcare, or engineering discipline, or a comparable field.
• At least six years of progressively responsible experience in quality assurance, computer system validation or assurance, IT quality, or a related area in regulated life sciences.
• Demonstrated independent QA oversight of GxP systems throughout their lifecycle, from risk assessment and validation through change control, periodic review, migration, and retirement.
• Experience reviewing and approving validation documentation and evaluating testing, traceability, and release readiness.
• Ability to assess data integrity and compliance risks and work effectively across quality, technology, operations, and vendor teams.

Benefits and work setup

The role is eligible for a discretionary annual bonus and benefits that include health coverage, retirement savings, life and disability insurance, parental leave, and paid sick and vacation time. The listed salary estimate is $91,500–$120,000 USD; actual compensation may depend on experience, skills, training, and work location. Candidates must be authorized to work in the country of employment without sponsorship.