Clinical Compliance Manager

🕒 6 dias atrás

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Thermo Fisher Scientific

SiteLinkedInTodas as Vagas

10.000+ funcionários

Fundada em 1956

🏥 Saúde

📦 Logística

🏭 Manufatura

Healthcare • Logistics • Manufacturing

A Thermo Fisher Scientific é a líder mundial em servir à ciência, com receita anual de mais de US$ 40 bilhões. Sua missão é capacitar os clientes a tornar o mundo mais saudável, limpo e seguro, apoiando a pesquisa em ciências da vida, solucionando desafios analíticos complexos, aumentando a produtividade dos laboratórios e melhorando a saúde dos pacientes por meio de diagnósticos e do desenvolvimento de terapias que transformam vidas. Com uma equipe global, oferece tecnologias inovadoras e serviços farmacêuticos por meio de marcas como Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon e PPD.

Descrição

• Develop and execute quality and compliance strategies and initiatives across the organization • Conduct complex internal and external audits and inspections • Perform technical document reviews and other GxP quality activities supporting clinical development programs • Oversee governance and compliance management processes • Develop and maintain quality guidance, reference materials, and compliance tools • Lead quality and compliance initiatives for clinical processes • Provide subject matter expertise on GxP regulations • Support risk assessment and mitigation activities • Develop, maintain, and improve quality management system documentation, policies, procedures, guidance documents, and training materials • Drive continuous improvement initiatives for quality systems and operational efficiency • Create and maintain tools, dashboards, and reports monitoring compliance activities and quality metrics • Collaborate across departments to promote best practices and build quality partnerships • Investigate quality issues and non-conformances, perform root cause analysis, and implement corrective and preventive actions • Lead or support internal audits, client audits, regulatory inspections, and investigative site audits • Mentor and coach junior auditors and quality professionals • Build relationships with internal stakeholders and designated client quality teams

🎯 Requisitos

• Bachelor's degree or an equivalent combination of education, training, and relevant experience • 8+ years of experience in clinical quality, regulatory compliance, clinical research, or a related field • Strong knowledge of GxP regulations and the end-to-end clinical trial process • Extensive experience with Quality Management Systems (QMS), SOPs, and regulatory inspections • Excellent verbal and written communication skills, including communicating scientific and technical information effectively • Demonstrated experience leading audits and mentoring or training team members • Strong analytical, problem-solving, risk assessment, and decision-making skills • Excellent organizational, prioritization, and project management abilities • Ability to build collaborative relationships and influence stakeholders across functions • Proficiency with Microsoft Office and quality management systems, with ability to quickly learn new technologies • Flexibility to travel as business needs require

🏖️ Benefícios

• Opportunities to grow your career • Professional development through mentoring and coaching • Collaboration with talented colleagues • Environment valuing innovation, integrity, and continuous learning • Reasonable accommodation for individuals with disabilities • Equal employment opportunity