Director, Quality Assurance – Combination Products

🔥 13 hours ago

🇺🇸 United States – Remote

💵 $170k - $250k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Vera Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

🏥 Healthcare

💼 Consulting

🧬 Biotechnology

Healthcare • Consulting • Biotechnology

Vera Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for immunological kidney diseases that improve patients’ lives. The company is advancing Atacicept through clinical development for IgA nephropathy (IgAN), running Phase 2b and Phase 3 trials, and pursuing programs in lupus nephritis and other immunologic conditions. Headquartered in Brisbane, CA, Vera emphasizes science-driven drug development, patient engagement, and sustainability.

📋 Description

• Oversee the quality and compliance of combination products • Develop and implement quality strategies and processes for combination products • Act as the QA contact for quality-related inquiries and issues concerning device and combination products • Collaborate with product development, manufacturing, clinical development, supply chain, commercial, quality, and regulatory affairs teams • Define and implement quality standards, specifications, methods, systems, and metrics for clinical and commercial quality operations • Monitor changes in medical device and combination product regulations and industry best practices • Participate in development, review, and approval of product documentation, including design control, risk management, and validation • Identify gaps and improvement opportunities within the Design History File and Risk Management, and track them to closure • Oversee external partners and suppliers for quality and compliance, including validation studies • Communicate quality and compliance status to senior management • Prepare for and execute regulatory audits and ensure observations are addressed on schedule • Serve as Quality representative on assigned product teams • Travel 5–15% domestically and internationally

🎯 Requirements

• Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field • 10+ years of experience in quality oversight of drug product device development, with a proven track record of successful product launches • Experience in quality oversight of design controls and combination products is required • In-depth knowledge of 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971, and EU MDR • Familiarity with combination product lifecycle management from initial design phase to commercialization • Experience with quality oversight of biological drug products and working CMOs is a plus • Excellent communication and interpersonal skills across the organization and with external partners • Ability to identify and resolve complex problems • Ability to operate in alignment with Vera’s Core Values

🏖️ Benefits

• Annual performance incentive bonus • New hire equity • Ongoing performance-based equity • Medical insurance • Dental insurance • Vision insurance • 401k match • Flexible time off • Paid holidays