Associate Director, Clinical Quality Assurance

🕒 Junho 23

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Vera Therapeutics, Inc.

SiteLinkedInTodas as Vagas

201 - 500 funcionários

🏥 Saúde

💼 Consultoria

🧬 Biotecnologia

Healthcare • Consulting • Biotechnology

Vera Therapeutics, Inc. é uma empresa de biotecnologia em estágio clínico focada no desenvolvimento de tratamentos para doenças renais imunológicas que melhorem a vida dos pacientes. A empresa está avançando com o Atacicept através do desenvolvimento clínico para nefropatia por IgA (IgAN), conduzindo testes de Fase 2b e Fase 3, e perseguindo programas em nefrite lúpica e outras condições imunológicas. Com sede em Brisbane, CA, a Vera enfatiza o desenvolvimento de medicamentos orientado pela ciência, o engajamento com os pacientes e a sustentabilidade.

Descrição

• Serve as the Clinical Quality Assurance representative on assigned clinical study teams, providing proactive guidance to ensure clinical trial conduct aligns with GCP and regulatory expectations. • Provide oversight of clinical quality events, investigations, and CAPAs, ensuring appropriate root cause analysis, corrective actions, and identification of systemic quality trends. • Analyze quality signals across studies, vendors, and operational processes to identify emerging risks and recommend mitigation strategies. • Contribute to governance of the clinical audit program, including risk-based selection of audits and oversight of Audit CAPA follow-up. Execution of audits is performed by the audit function. • Serve as a quality interface with CROs and vendor quality representatives to ensure appropriate management and resolution of quality issues. • Support inspection readiness activities and provide first-line Clinical QA support during sponsor regulatory inspections, including preparation and follow-up actions. • Review and provide input on new or revised SOPs and controlled documents to ensure alignment with regulatory requirements and consistency across organizational procedures. • Provide input on training assignments and training matrices to ensure procedures are appropriately implemented across functional roles. • Participate in process improvement initiatives that support the development and strengthening of the Quality Management System, including the evaluation, assessment, and implementation of quality governance, processes, and systems.

🎯 Requisitos

• Bachelor’s degree in life sciences, pharmacy, or related scientific discipline required. Advanced degree preferred. • Approximately 8+ years of industry experience, including leadership in clinical quality oversight or quality governance. • Strong applied knowledge of global GxP regulations applicable to clinical development, including: • Good Clinical Practice (GCP) • Good Pharmacovigilance Practice (GVP) • Good Laboratory Practice (GLP) • Experience with the following is desired: • Quality management and oversight of clinical trials • Quality event and CAPA management • Regulatory inspection readiness and inspection support • Risk-based quality management approaches • Planning of clinical audits (including sites, internal audits) • Developing metrics and reviewing issues for quality signals and trends • SOP governance through controlled document reviews • Training matrix or training governance activities • Relevant certifications such as RQAP, CQA, CCRC, or RAC are considered a plus.

🏖️ Benefícios

• Medical, dental, and vision insurance • 401k match • Flexible time off • Paid holidays • Annual performance incentive bonus • New hire equity • Ongoing performance-based equity