Quality & Compliance Manager, Computer System Validation

Precision For Medicine

. Manage quality oversight and lifecycle validation of GxP computerized systems supporting CRO and laboratory operations .

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 and computer system validation within regulated life sciences environments, ensuring compliance with GxP standards and data integrity principles. Proficient in managing lifecycle validation, risk assessments, and supporting audits and inspections.

Highest-signal resume keywords

Quality Assurance OversightComputer System ValidationGxP ComplianceRisk-Based ValidationRegulatory Inspection Support

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Quality AssuranceComputer System ValidationRisk AssessmentsValidation PlansData Integrity PrinciplesGxP StandardsSaaS SolutionsLaboratory Instrument SoftwareRegulatory ComplianceValidation Summary Reports

Soft Skills

CollaborationCommunicationContinuous ImprovementLeadership

Tools & Technologies

Cloud ServicesComputerized SystemsValidation ToolsAudit Management Software

Certifications & Qualifications

Relevant Professional Certification

Industry Keywords

CROClinical ResearchGood Clinical PracticeGood Laboratory PracticeFDA RequirementsEU Annex 11GAMP Guidance

Tech Stack

Tools & technologies

Cloud

About the role

Key responsibilities & impact

Manage quality oversight and lifecycle validation of GxP computerized systems supporting CRO and laboratory operations
Provide independent, risk-based Quality Assurance oversight from initial assessment and implementation through operation, periodic review, significant change, and retirement
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 systems are fit for intended use, maintain data integrity, and comply with procedures, client commitments, and regulatory requirements
Oversee validated-state activities including changes, incidents, deviations, CAPAs, upgrades, data migrations, periodic reviews, and decommissioning
Support qualification and ongoing oversight of software, cloud, data, and computerized-system service providers
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; coordinate responses to observations
Establish and report metrics for validation status, lifecycle compliance, overdue activities, deviations, CAPAs, supplier performance, and emerging risks
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 collaborating 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 qualify
Preferred: Master’s degree, regulated-industry experience, GxP environment experience, team-management experience, laboratory and clinical platform experience, Agile/Waterfall/hybrid methodology experience, inspection and audit experience, relevant professional certification, and familiarity with GAMP guidance and risk-based computer software assurance principles

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