Quality & Compliance Manager, Computer System Validation

Job Description:

• 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:

• 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:

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