Quality & Compliance Manager – Computer System Validation

Precision Medicine Group

. Provide independent, risk-based Quality Assurance oversight of GxP computerized systems throughout the system lifecycle .

Posted 10/5/2026full-timeRemote • United StatesMid-LevelSenior💰 $91,500 - $120,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates expertise in Quality Assurance oversight of GxP computerized systems, ensuring compliance with regulatory requirements and data integrity throughout the system lifecycle. Proficient in risk-based validation approaches and collaboration with cross-functional teams to support audits and continuous improvement initiatives.

Highest-signal resume keywords

Quality Assurance OversightGxP Computerized SystemsComputer System ValidationRisk-Based Validation ApproachesRegulatory Compliance

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Computer System ValidationQuality AssuranceRisk AssessmentsValidation PlansTest Evidence ReviewData Integrity PrinciplesSupplier QualificationRegulatory InspectionsCAPA ManagementValidation Summary Reports

Soft Skills

CollaborationCommunicationProblem-SolvingContinuous ImprovementStakeholder Engagement

Tools & Technologies

Laboratory Information SystemsElectronic Laboratory NotebooksChromatography Data SystemsAutomated WorkflowsCloud SolutionsSaaS Solutions

Industry Keywords

FDA Electronic-Record RequirementsEU Annex 11ICH Good Clinical PracticeGood Laboratory PracticeRegulated Life Sciences Environment

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

Provide independent, risk-based Quality Assurance oversight of GxP computerized systems throughout the system lifecycle
Review and approve validation and assurance deliverables, including risk assessments, validation plans, requirements, traceability documentation, test evidence, deviations, validation summary reports, and release-readiness documentation
Ensure computerized systems are fit for intended use, maintain data integrity, and comply with procedures, client commitments, and regulatory requirements
Provide QA oversight for clinical and laboratory computerized systems, including clinical platforms, laboratory information systems, electronic laboratory notebooks, chromatography data systems, instrument software, interfaces, automated workflows, and data repositories
Oversee the ongoing validated state by evaluating changes, incidents, deviations, CAPAs, upgrades, data migrations, periodic reviews, and decommissioning
Identify and escalate compliance or data-integrity risks and verify remediation
Support qualification and ongoing oversight of software, cloud, data, and computerized-system service providers
Partner with Quality, IT, Information Security, Clinical Operations, Laboratory Operations, system owners, and vendors
Develop and improve policies, procedures, templates, tools, and training for computer system validation and computer software assurance
Prepare for and support sponsor audits, regulatory inspections, and internal audits
Establish and report metrics for validation status, lifecycle compliance, overdue activities, deviations, CAPAs, supplier performance, and emerging risks
Use trends and lessons learned to drive continuous improvement and communicate significant issues to Quality and business leadership

Requirements

What you’ll need

Bachelor’s degree in life sciences, computer science, information systems, engineering, healthcare, or another relevant scientific or technical discipline
Minimum of six years of progressively responsible experience in Quality Assurance, computer system validation, computer software assurance, information technology quality, or related discipline within a regulated life sciences environment
Experience providing independent QA oversight of GxP computerized systems throughout the system lifecycle
Experience reviewing and approving computer system validation or assurance documentation
Working knowledge of FDA electronic-record and electronic-signature requirements, EU Annex 11, ICH Good Clinical Practice, Good Laboratory Practice, and data-integrity principles
Experience supporting computerized systems used in CRO, clinical research, or laboratory operations
Experience with risk-based validation and assurance approaches for configurable commercial software, SaaS solutions, hosted platforms, system interfaces, laboratory instrument software, and internally configured or developed solutions
Experience supporting supplier qualification, system or vendor audits, sponsor audits, regulatory inspections, and remediation of computerized-system compliance observations
Experience working collaboratively with system owners, IT, Information Security, Clinical Operations, Laboratory Operations, Quality Assurance, vendors, and other stakeholders in a matrixed and geographically dispersed organization
Equivalent combination of education, professional training, and experience may provide the required knowledge, skills, and abilities

Benefits

Comp & perks

Discretionary annual bonus
Health insurance
Retirement savings benefits
Life insurance
Disability benefits
Parental leave
Paid time off for sick leave and vacation