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 Medicine Group

SiteLinkedInTodas as Vagas

1001 - 5000 funcionários

Fundada em 2012

💼 Consultoria

🏥 Saúde

📦 Logística

💰 $35.200.000 Venture Round em 2021-03

Consulting • Healthcare • Logistics

A Precision Medicine Group é uma equipe global de especialistas dedicada à medicina de precisão, que combina ciências laboratoriais avançadas, informática translacional, assuntos regulatórios, insights de pagadores e comunicações de marketing. A empresa foca em superar desafios de desenvolvimento de produtos e de comercialização para clientes dos setores farmacêutico e de ciências da vida. Seus serviços incluem P&D orientada por biomarcadores, bem como suporte à comercialização para organizações de ciências da vida, do lançamento à maturidade do produto. A Precision Medicine Group opera por meio de duas frentes principais: Precision for Medicine e Precision AQ, especializadas em soluções clínicas e comerciais, respectivamente.

Descrição

• 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

🎯 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 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

🏖️ Benefícios

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