Associate Director, Clinical Quality Assurance Auditor

Vaga não está no LinkedIn

🕒 Março 13

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $195.300 - $227.850 / ano

⏰ Tempo Integral

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

🦅 Patrocina Visto H1B

Esta empresa já patrocinou vistos H1B no passado.

Candidatar-se

Encontrar Vagas Remotas Similares

Configurar Alerta de Email para Novas Vagas

📊 Verifique sua pontuação de currículo para esta vaga

Melhore suas chances de conseguir uma entrevista verificando sua pontuação de currículo antes de se candidatar.

Enviar Currículo

Cytokinetics

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 1998

🏥 Saúde

💼 Consultoria

🏭 Manufatura

💰 $450.000.000 Post-IPO Debt em 2022-06

Healthcare • Consulting • Manufacturing

A Cytokinetics é uma empresa biofarmacêutica em fase avançada que se concentra na descoberta, desenvolvimento e comercialização de potenciais medicamentos destinados a melhorar a função muscular. A empresa está particularmente ativa no desenvolvimento de tratamentos para doenças cardiovasculares e neuromusculares, como insuficiência cardíaca, cardiomiopatia hipertrófica e outras condições de comprometimento da função muscular. A Cytokinetics possui um robusto pipeline de ativadores e inibidores musculares de pequenas moléculas e está comprometida em melhorar a vida dos pacientes por meio de seus esforços de pesquisa e desenvolvimento científico. A missão da empresa gira em torno de empoderar o músculo e, assim, empoderar vidas, com os pacientes sendo o foco central de suas atividades. Com sede em South San Francisco, a Cytokinetics tem sido pioneira no campo da biologia muscular há mais de 25 anos.

Descrição

• Serve as the CQA audit program process owner and accountable for the day-to-day activities of the audit program, including audit coordinating, report reviews, response review, and CAPA follow up, and audit closures • Serve as the principal lead auditor for GCP, GVP, and GLP audits, including investigator sites, CROs, vendors, laboratories, and internal functional areas. • Develop, implement, and maintain a risk-based global clinical audit program, ensuring comprehensive coverage of company-sponsored trials and critical vendors • Analyze and manage audit program metrics, trends to identify key compliance risks and improvement opportunities; communicate findings to senior management • Lead inspection readiness activities for global health authority inspections, including mock inspections, SME training and preparation, and documentation review • Assist with the design and the creation/management/maintenance of quality plans and metrics • Oversee and coordinate with contract auditors on internal and external quality audits of clinical vendors and investigator sites • Assist with quality review of key clinical documents (e.g. clinical protocol, ICFs, CSRs, case report form) and clinical SOPs • Design and conduct GCP Training for functional departments, act as the primary trainer for the auditor program • Support maintenance and continuous improvement of the clinical quality management system (QMS), including SOPs, training, and compliance metrics • Provide mentoring and oversight to QA staff and foster a culture of quality and accountability across clinical teams • Represent CQA in assigned projects and study/program team meetings to address quality issues that may arise, including identification and resolution and be an advocate for quality and regulatory compliance.

🎯 Requisitos

• Bachelor's degree in life sciences • 10+ years of progressive global quality/regulatory compliance background in pharma/biotech or medical device industries, with a hands-on role in quality audits and quality system preferred • Current and strong working knowledge of United States Code of Federal Regulations and European regulations and guidance, including ICH-GCP Guidance requirements governing clinical research conduct and pharmacovigilance operations • Experience with electronic Quality Management Systems and Trial Master File • Auditor certification is preferred • Up to 60% travel may be required • Experience in managing or supporting clinical trial or Drug Safety-related regulatory inspections a plus • Ability to lead cross-functional teams, independently prioritize work and manage multiple priorities while maintaining quality and GCP compliance objectives • Ability to use expertise and skills to contribute and achieve Cytokinetics’ company objectives and principles in creative and effective ways.