Senior Manager, Clinical Quality Assurance

🔥 0 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $150k - $172k / year

⏰ Full Time

🟠 Senior

🔧 QA Engineer (Quality Assurance)

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Artiva Biotherapeutics

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51 - 200 employees

💰 Series B on 2021-02

Artiva Biotherapeutics is an immunotherapy company with the ability to produce off-the-shelf, allogeneic NK cell therapies at a massive scale. Our mission is to develop effective, safe and accessible cell therapies for patients with devastating autoimmune diseases and cancers. Our lead program, AlloNK®, is an allogeneic, non-genetically modified NK cell therapy candidate designed to enhance the activity of monoclonal antibodies or NK cell engagers. AlloNK is currently in clinical trials in combination with rituximab for treatment of systemic lupus erythematosus (SLE) in patients with active lupus nephritis and for treatment of Non-Hodgkin Lymphoma, as well as in combination with Affimed’s innate cell engager AFM13 for the treatment of patients with relapsed/refractory CD30-positive lymphomas.

📋 Description

• 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.

🎯 Requirements

• 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.

🏖️ Benefits

• 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.