Quality & Compliance Manager, Computer System Validation

🕒 3 dias atrás

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $91.500 - $120.000 / ano

⏰ Tempo Integral

🟡 Pleno

🟠 Sênior

🚔 Conformidade

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Precision For Medicine

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

🏥 Saúde

💼 Consultoria

📦 Logística

💰 $75.000.000 Private Equity Round em 2015-12

Healthcare • Consulting • Logistics

A Precision For Medicine é uma organização líder especializada em apoiar o desenvolvimento e a comercialização de terapias inovadoras, particularmente em oncologia, doenças raras e condições autoimunes. Com uma gama abrangente de serviços, incluindo gestão de ensaios clínicos, serviços de laboratório e coleta de biospecimens, eles integram capacidades avançadas de biomarcadores e soluções de manufatura para simplificar os complexos processos de desenvolvimento clínico. Sua missão é acelerar a pesquisa e trazer soluções médicas que mudem a vida dos pacientes, superando as ineficiências tradicionais geralmente encontradas no cenário de desenvolvimento farmacêutico.

Descrição

• 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

🎯 Requisitos

• 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

🏖️ Benefícios

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