Director, Quality Assurance – Combination Products

November 13

🏄 California – Remote

Although this job is listed in California, this company may be open to hiring remote in other states.

💵 $170k - $230k / year

⏰ Full Time

🔴 Lead

🔧 QA Engineer (Quality Assurance)

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Vera Therapeutics, Inc.

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Biotechnology • Pharmaceuticals

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.

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

📋 Description

• Oversee the quality and compliance of combination products, ensuring they meet regulatory standards and company objectives. • Develop and implement quality strategies and processes for combination products, in alignment with company goals and regulatory requirements. • Act as the QA contact for all quality-related inquiries and issues concerning device and combination products. • Collaborate with cross-functional teams, including product development, manufacturing, clinical development, supply chain, commercial, quality, and regulatory affairs, to ensure quality and compliance throughout the combination product lifecycle. • Help define and implement as appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations. • Stay up-to-date with changes in medical device and combination product regulations and industry best practices. • Participate in the 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 to closure. • Collaborate with external partners and suppliers to ensure quality and compliance with company standards. Perform quality assurance oversight for validation studies conducted by external partners. • Communicate effectively with senior management to provide updates on the status of quality and compliance for medical device / combination product. • Participate in preparation for and execution of regulatory audits. Ensures audit observations related to functional area are addressed appropriately and completed on schedule. • Act as the Quality representative on assigned product teams to advocate compliance and quality assurance. • Availability for 5-15% travel, both domestically and internationally.

🎯 Requirements

• Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred. • 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 global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, ISO 14971 and EU MDR. • Familiar 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 in working across the organization and external partners. • Ability to identify and resolve complex problems through effective use of technical and interpersonal skills. • Ability to operate in alignment with Vera’s Core Values.

🏖️ Benefits

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