Karius
Karius is a life sciences company focused on saving lives from infectious diseases.
Life Sciences • Diagnostics • Genomics • Data Science • Bioinformatics
51 - 200
Director, Quality Assurance
June 12
🏢 In-office - Bay Area
Karius
Karius is a life sciences company focused on saving lives from infectious diseases.
Life Sciences • Diagnostics • Genomics • Data Science • Bioinformatics
51 - 200
Description
• Define and build the quality team • Lead the implementation, management and operation of Karius’ quality function • Develop and plan innovative quality and regulatory strategies in life cycle product management • Manage all aspects of the quality assurance lifecycle • Collaborate with R&D, product, manufacturing, clinical, and regulatory teams • Lead batch record review, lot disposition, material release, internal audit program, deviation handling, change controls, and quality events processes
Requirements
• BS in molecular biology, microbiology or related field; advanced degree (MS/PhD) preferred • 8+ years of Quality Management, Quality Assurance, and Quality Control leadership experience in Diagnostics, Biotechnology, or relatable life sciences fields • Experience with implementation, management and operation of FDA-compliant and LDT quality systems • Strong understanding of diagnostic assay development and production processes • Demonstrated ability to lead cross-functional teams and manage complex projects in a fast-paced startup environment • Excellent communication and interpersonal skills
Benefits
• Comprehensive health benefits • Equity and stock options • 401(k) retirement plan • Paid time off policy
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