Associate Director, Clinical Quality Assurance Auditor

🕒 Março 13

🇺🇸 Estados Unidos – Remoto (EUA)

💵 $195.300 - $227.850 / ano

⏰ Tempo Integral

🟠 Sênior

🔧 Engenheiro de QA (Qualidade de Software)

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Cytokinetics

SiteLinkedInTodas as Vagas

201 - 500 funcionários

Fundada em 1998

🧬 Biotecnologia

💊 Farmacêutico

⚕️ Seguro de Saúde

💰 $450.000.000 Post-IPO Debt em 2022-06

Biotechnology • Pharmaceuticals • Healthcare Insurance

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.