Clinical Quality Assurance Manager

🕒 5 dias atrás

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WEP Clinical

SiteLinkedInTodas as Vagas

51 - 200 funcionários

Fundada em 2008

💼 Consultoria

📦 Logística

💊 Farmacêutico

Consulting • Logistics • Pharmaceuticals

A WEP Clinical é uma Provedora de Serviços Farmacêuticos que se especializa em Programas de Desenvolvimento de Medicamentos, Soluções de Acesso a Tratamentos e Acesso ao Mercado e Comercialização. A empresa foca em fornecer suporte crítico ao longo de todo o percurso de desenvolvimento e comercialização de medicamentos, ajudando patrocinadores a avançarem com suas medicações e a melhorarem o acesso dos pacientes. A WEP Clinical oferece serviços como serviços de ensaios clínicos, programas de acesso expandido, programas de pacientes nomeados pós-aprovação e consultoria de acesso ao mercado, garantindo que as terapias tão necessárias alcancem pacientes em todo o mundo.

Descrição

• Oversee, implement, and continuously improve GCP quality systems supporting global clinical operations and decentralized clinical trials • Provide quality leadership and strategic quality advice to operational teams and departments • Manage day-to-day Clinical Quality team activities, including workload planning, performance management, coaching, training, and professional development • Oversee QMS records, including deviations, non-conformances, complaints, protocol deviations, CAPAs, change controls, risk assessments, and quality events • Review and approve investigations and monitor CAPA effectiveness • Track inspection trends, quality metrics, KPIs, and emerging compliance risks • Provide quality oversight for nursing services, home healthcare, investigational product handling, source documentation, and patient-facing clinical processes • Lead quality oversight for new services, vendors, systems, operational changes, computerized system validation, equipment qualification, and process validation • Review clinical trial documentation including protocols, ICFs, eCRFs, Pharmacy Manuals, Monitoring Plans, and essential documents • Support vendor qualification and oversight, audits, requalification, Quality Technical Agreements, and vendor performance monitoring • Lead Sponsor audits, regulatory inspections, licensing authority inspections, and client qualification audits • Drive continuous improvement, QMS updates, quality governance, risk-based decision-making, stakeholder collaboration, patient safety, and operational excellence

🎯 Requisitos

• Bachelor's Degree or higher; preference for pharmaceutical, life sciences, or engineering concentration • 5–7 years’ experience in a Clinical Quality related role • Minimum 2–3 years of people leadership or supervisory experience preferred • Experience within a CRO, pharmaceutical, biotechnology, healthcare, or other regulated clinical environment • Demonstrated experience supporting global clinical trials and decentralized clinical trial activities • Experience leading Sponsor audits, regulatory inspections, internal audits, and/or supplier audits • Practical experience leading quality investigations, CAPAs, root cause analyses, and quality risk assessments • Experience with eQMS, eTMF, Microsoft Office, and quality management software applications • Strong knowledge of ICH E6(R3), FDA, EU CTR, MHRA, GCP, GDPR where applicable, and other global regulatory expectations • Strong understanding of risk-based quality management, computerized system validation, validation lifecycle principles, and GDP/clinical trial supply logistics where applicable • Ability to manage multiple quality activities in a fast-paced global environment • Strong organization, project management, attention to detail, communication, analytical, stakeholder management, and influencing skills • Ability to work effectively with Sponsors, auditors, inspectors, vendors, senior leadership, and cross-functional teams • Resume must be submitted in English • Candidates must reside in a U.S. state where the company is authorized to hire; the role is not eligible for residents of California, Colorado, New York, Washington, New Jersey, Massachusetts, Illinois, Hawaii, and District of Columbia

🏖️ Benefícios

• Medical, dental, and vision insurance • FSA, HSA • Voluntary Critical Illness, Hospital Indemnity, and Accident Insurance • Group short-term and long-term disability insurance • Group Life Insurance • 401K safe harbor plan and company match • Paid vacation, holiday, sick and volunteer time • Paid maternity & paternity leave • Wellness, growth and development initiatives • Team events • Inclusive, supportive work environment