Principal Quality Manager

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🕒 Junho 11

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TFS HealthScience - Contract Research Organization

SiteLinkedInTodas as Vagas

501 - 1000 funcionários

Fundada em 2007

💼 Consultoria

🏥 Saúde

📦 Logística

Consulting • Healthcare • Logistics

A TFS HealthScience é uma das principais Organizações de Pesquisa por Contrato (CRO) globais, que colabora com empresas de biotecnologia e farmacêuticas para impulsionar o desenvolvimento clínico. Oferece um amplo portfólio de soluções, incluindo desenvolvimento clínico de Fases I–III, estudos de evidências do mundo real (Fase IV) e soluções estratégicas de resourcing (alocação de profissionais). A TFS HealthScience é especializada em diversas áreas terapêuticas, como dermatologia, medicina interna, neurociências, oncologia e hematologia, oftalmologia, pediatria, doenças raras e medicamentos órfãos. Seu objetivo é levar tratamentos aos pacientes com mais rapidez, combinando capacidades full service e alcance global com a flexibilidade e a abordagem personalizada de uma CRO de médio porte.

Descrição

• Maintains quality oversight for multiple projects, vendors, and/or systems, ensuring consistent and compliant execution. • Acts as escalation point for complex, high-risk or systemic quality issues, inspection risks, and compliance concerns within assigned scope. • Leads complex investigations, including suspected serious breaches, fraud and misconduct and systemic quality issues; ensures robust CAPA development, effectiveness checks, and trend analysis. • Acts as lead auditor for routine audits and leads complex audits and inspections; defines inspection response strategy, coordinates execution, and supports senior management during high‑risk or regulatory‑critical inspections. • Leads inspection readiness activities. • Acts as subject matter expert for one or more QMS elements (e.g. CAPA, Audit Program, Vendor Quality Management, Inspection Readiness, Training Compliance, CSV Quality Oversight) and supports continuous improvement initiatives within those areas. • Develops, reviews, and maintains controlled documents within assigned scope and ensures alignment of assigned processes, procedures, and tools with the company QMS and applicable GxP regulations. • Leads and/or performs quality risk assessments and participates in risk management reviews. • Reports KQIs, KPIs, quality metrics, trends, and improvement opportunities. • Performs audits, acts as lead auditor for complex audits and supports audit program planning and execution. • Mentors auditors and supports audit quality and consistency. • Leads vendor qualification and oversight activities, including risk assessments, RFIs, performance monitoring, and re‑qualification activities.

🎯 Requisitos

• Bachelor’s degree in Life Sciences or equivalent, or relevant experience in quality management and auditing. • Minimum 10 years of demonstrated experience in quality management and quality assurance processes. • Minimum 7 years’ audit experience across different types of GCP and other GxP audits; lead auditor experience preferred. • Experience working in clinical research environments (CRO and/or Sponsor). • Excellent knowledge of GxP regulations and guidance with the ability to interpret and translate requirements into pragmatic processes • Strong understanding of Quality Management Systems, quality standards, inspection requirements, and inspection response management. • Proficiency in MS Office, data analysis tools, and quality assurance software/eQMS tools.

🏖️ Benefícios

• We provide a competitive compensation package • Comprehensive benefits • Opportunity for personal and professional growth in a rewarding environment