Associate Director, Clinical Quality Assurance

🕒 vor 1 Monat

Jetzt Bewerben

Ähnliche Remote-Jobs finden

E-Mail-Benachrichtigung für neue Jobs einrichten

📊 Überprüfen Sie Ihre Lebenslauf-Bewertung für diese Stelle

Verbessern Sie Ihre Chancen auf ein Vorstellungsgespräch, indem Sie Ihre Lebenslauf-Bewertung vor der Bewerbung überprüfen.

Lebenslauf hochladen

Vera Therapeutics, Inc.

WebsiteLinkedInAlle Stellen

201 - 500 Mitarbeiter

🏥 Gesundheitswesen

💼 Beratung

🧬 Biotechnologie

Healthcare • Consulting • Biotechnology

Vera Therapeutics, Inc. ist ein biopharmazeutisches Unternehmen in der klinischen Entwicklungsphase, das sich auf die Entwicklung von Behandlungen für immunologische Nierenerkrankungen konzentriert, um das Leben der Patienten zu verbessern. Das Unternehmen treibt die klinische Entwicklung von Atacicept zur Behandlung der IgA-Nephropathie (IgAN) voran und führt Studien der Phase 2b und Phase 3 durch. Darüber hinaus verfolgt es Programme zur Behandlung von Lupusnephritis und anderen immunologischen Erkrankungen. Mit Hauptsitz in Brisbane, Kalifornien, legt Vera besonderen Wert auf wissenschaftsorientierte Arzneimittelentwicklung, Patientenengagement und Nachhaltigkeit.

Beschreibung

• 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.

🎯 Anforderungen

• 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.

🏖️ Vorteile

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