Associate Director, Clinical Quality Assurance

🕒 August 6

🏄 California – Remote

🏄 California – Remote

💵 $172k - $195k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Artiva Biotherapeutics

WebsiteLinkedInAll Job Openings

51 - 200 employees

🧬 Biotechnology

🏥 Healthcare

💊 Pharmaceuticals

💰 Series B on 2021-02

Biotechnology • Healthcare • Pharmaceuticals

Artiva Biotherapeutics is an immunotherapy company dedicated to making safe and effective cell therapies accessible to any cancer patient who may benefit. The company specializes in producing off-the-shelf, allogeneic NK cell therapies at a massive scale. Its mission focuses on developing effective, safe, and accessible therapies for patients suffering from autoimmune diseases and cancers. Notably, their lead program, AlloNK®, is a non-genetically modified NK cell therapy candidate currently undergoing clinical trials for treatments of systemic lupus erythematosus and Non-Hodgkin Lymphoma, among others.

📋 Description

• Serve as the Clinical QA lead for assigned clinical programs and provide quality oversight across all phases of clinical development. • Develop, implement, and conduct risk-based GCP quality oversight strategies. • Lead investigations of significant GCP quality and compliance events, including CAPA development and effectiveness oversight. • Plan, conduct, and manage contract auditors for routine and for-cause audits of clinical investigator sites, CROs, and vendors. • Assess and communicate audit findings' impact on sponsor oversight, subject safety, data integrity, protocol compliance, and internal processes. • Maintain required documentation and quality records. • Lead inspection readiness activities and support regulatory authority inspections. • Collaborate with internal teams to ensure quality compliance across clinical development. • Define and implement review strategies for key regulatory documents associated with submissions. • Lead development and implementation of clinical quality procedures with Clinical Development. • Identify GCP compliance risks and develop mitigation actions. • Monitor emerging regulations and communicate relevant changes. • Provide QA consultation and participate in risk-based sponsor oversight activities. • Define, support, and deliver GCP training for Clinical Operations staff. • Define and present quality metrics and trend analyses. • Participate in interviewing and hiring Clinical Quality Assurance staff.

🎯 Requirements

• BS or BA in a scientific field. • 8+ years of clinical and/or QA experience in biologics or pharma. • 4+ years of Clinical QA experience. • Knowledge and hands-on experience with regulatory inspections and clinical investigator site, vendor, and internal audits. • Thorough knowledge of current Good Clinical Practices and Good Clinical Laboratory Practices for all phases of cell therapy product human clinical trials. • Expert-level understanding of CLIA and CAP. • Knowledge of ICH, GCP, GCLP, data privacy, and other applicable pharmaceutical/biopharma regulations and requirements. • Sound scientific training and communications knowledge. • Expert knowledge of quality regulations, current industry practices, and their interpretation and application. • Computer skills required to operate Microsoft Word, Project, and Excel. • Preferred: experience in small or emerging biotechnology companies. • Familiarity with global pharmacovigilance regulations and quality systems preferred. • Experience supporting or overseeing GVP quality activities, safety vendors, or pharmacovigilance processes preferred. • Demonstrated understanding of the interface between GCP and GVP requirements preferred.

🏖️ Benefits

• A beautiful facility • An entrepreneurial, highly collaborative, and innovative environment • 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 • Recognition program, Bonus.ly, where you can trade in points earned for things you want