Head of Quality Assurance

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🕒 Maio 5

🇺🇸 Estados Unidos – Remoto (EUA)

⏰ Tempo Integral

🔴 Especialista

🔧 Engenheiro de QA (Qualidade de Software)

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Clinical Outcomes Solutions

SiteLinkedInTodas as Vagas

51 - 200 funcionários

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

Biotechnology • Pharmaceuticals • Healthcare Insurance

A Clinical Outcomes Solutions é uma consultoria global de desfechos clínicos que oferece suporte e serviços abrangentes em todos os aspectos da pesquisa de Avaliação de Desfecho Clínico (COA). A empresa ajuda a informar o cuidado ao paciente capturando a voz do paciente por meio de métodos científicos inovadores. Ela orienta as organizações a navegar nas complexidades da pesquisa de desfechos clínicos, elaborando estratégias e soluções para capturar dados precisos. Confiada por empresas farmacêuticas e biotecnológicas, a empresa garante conformidade regulatória e otimização dos resultados dos pacientes.

Descrição

• Lead and evolve Cytel’s global Quality Assurance strategy in alignment with business growth and regulatory expectations • Oversee, maintain, and continuously enhance the Quality Management System (QMS) • Serve as a senior leader during sponsor audits and regulatory inspections • Drive modernization of QA through adoption of digital tools, automation, and AI-enabled solutions • Improve consistency and reduce variability in audit readiness, execution, and responses • Partner closely with operational and functional teams to embed quality into day-to-day execution • Streamline QA processes to reduce unnecessary burden while maintaining robust compliance • Build, mentor, and develop a high-performing global QA team

🎯 Requisitos

• Significant experience in Quality Assurance within a CRO, pharmaceutical, or biotechnology environment • Strong expertise in GxP regulations and audit/inspection processes • Proven experience leading sponsor audits and regulatory interactions • Demonstrated success in improving and modernizing QA processes • Experience leveraging technology, automation, or AI to enhance quality systems strongly preferred, with an emphasis on practical, fit-for-purpose solutions rather than large-scale transformation initiatives • Strong business acumen and the ability to influence and partner effectively with senior stakeholders

🏖️ Benefícios

• Opportunity to build on a strong foundation and position Quality as a competitive advantage • High-impact leadership role with visibility across the organization and with clients • Collaborative environment with deeply experienced operational teams • Meaningful opportunity to shape a modern, scalable, technology-enabled quality function