Senior Manager, Clinical Quality Assurance

🕒 July 10

🏄 California – Remote

🏄 California – Remote

💵 $150k - $172k / year

⏰ Full Time

🟠 Senior

🏥 Clinical Operations

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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 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.