Senior Manager, Clinical Quality Assurance

🕒 vor 21 Tagen

🏄 California – Remote

🏄 California – Remote

💵 $150.000 - $172.000 / Jahr

⏰ Vollzeit

🟠 Senior

🔧 QA-Ingenieur (Qualitätssicherung)

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Artiva Biotherapeutics

WebsiteLinkedInAlle Stellen

51 - 200 Mitarbeiter

🧬 Biotechnologie

🏥 Gesundheitswesen

💊 Pharmazie

💰 Series B im 2021-02

Biotechnology • Healthcare • Pharmaceuticals

Artiva Biotherapeutics ist ein Immuntherapie-Unternehmen mit der Fähigkeit, gebrauchsfertige, allogene NK-Zelltherapien in großem Maßstab zu produzieren. Unser Ziel ist es, effektive, sichere und zugängliche Zelltherapien für Patienten mit schweren Autoimmunerkrankungen und Krebs zu entwickeln. Unser Hauptprogramm, AlloNK®, ist ein allogener, nicht genetisch modifizierter NK-Zelltherapie-Kandidat, der entwickelt wurde, um die Aktivität von monoklonalen Antikörpern oder NK-Zell-Engagern zu verstärken. AlloNK befindet sich derzeit in klinischen Studien in Kombination mit Rituximab zur Behandlung von systemischem Lupus erythematodes (SLE) bei Patienten mit aktiver Lupusnephritis und zur Behandlung von Non-Hodgkin-Lymphom sowie in Kombination mit Affimeds angeborenem Zell-Engager AFM13 zur Behandlung von Patienten mit wiederkehrenden/refraktären CD30-positiven Lymphomen.

Beschreibung

• Serve as the Clinical QA lead for assigned clinical programs and provide quality oversight across all phases of clinical development to ensure compliance with ICH-GCP, applicable regulations, and Artiva’s procedures. • Implement and conduct risk-based GCP quality oversight strategies for assigned clinical programs. • Conduct investigations of clinical investigator site issues, GCP quality issue investigations, determine root cause, corrective and preventive actions, and ensure appropriate and adequate documentation. • Plan, conduct/manage contract auditors, and oversee risk-based routine and for-cause audits of investigator sites, CROs, vendors, processes. • Assess and communicate the impact of audit findings on PI/Sponsor oversight, subject safety, data integrity, and business operations. • Maintain required documentation and quality records in accordance with Artiva procedures. • Support inspection readiness activities and participate in regulatory health authority inspections and inspection response activities. • Interact with internal teams and supporting functions to ensure quality compliance across all aspects of clinical development. • Represent Clinical QA on study teams and work collaboratively with all development functional areas. • Review key company documents associated with INDs, protocols, Investigator Brochure(s) and other relevant clinical trial documents for compliance with applicable regulations. • Implement a strategy to provide a review of key regulatory documents associated with regulatory submissions. • Identify GCP compliance risks and develop appropriate courses of action in partnership with the Clinical Department. • Maintain awareness of emerging regulations, guidance documents, and best industry practices and communicate relevant changes to management. • Provide QA consultation and participate in risk-based sponsor oversight activities. • Support and deliver GCP training for Clinical Operations staff, contributing to the broader clinical quality training program. • Present quality metrics and trend analyses.

🎯 Anforderungen

• BS or BA in a scientific field • 6+ years of clinical and/or QA experience in biologics or pharma • 3+ years of Clinical QA experience • Knowledge and hands on experience in regulatory inspections, clinical investigator site/vendor/internal audits • Thorough knowledge of current Good Clinical Practices as they relate to all phases of cell therapy product human clinical trials • Expert level of understanding of CLIA, CLIP, CAP • Knowledge of ICH, GCP, GCLP, Data Privacy and other applicable regulations and requirements in the pharmaceutical/biopharma industry • Sound basis of scientific (Training/Communications) knowledge • Expert knowledge of quality regulations, current industry practices, and strong experience with interpretation and application • Computer skills required to operate Microsoft Word, Project, and Excel programs.

🏖️ Vorteile

• Medical, Dental, and Vision • Group Life Insurance • Long Term Disability (LTD) • 401(k) Retirement Plan • Employee Assistance Program (EAP) • Flexible Spending Account (FSA) • Paid Time Off (PTO) • Company paid holidays, including the year-end holiday week • Our recognition program, Bonus.ly, is where you can trade in points earned for things you want.