Vera Therapeutics, Inc.

Compensation

Full Description

Note: The job is a remote job and is open to candidates in USA. Vera Therapeutics is a late clinical-stage biotechnology company focused on developing treatments for serious immunological diseases. The Director, Quality Assurance will oversee the quality oversight of design controls and risk management of combination product projects, ensuring they meet regulatory standards and are safe for patient use. Responsibilities • 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 Skills • 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 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 in 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 • Advanced degree preferred • Experience with quality oversight of biological drug products and working CMOs in a plus Benefits • Medical, dental, and vision insurance • 401k match • Flexible time off • A number of paid holidays Company Overview • Vera Therapeutics, Inc. It was founded in 2016, and is headquartered in South San Francisco, California, USA, with a workforce of 201-500 employees. Its website is https://veratx.com/. Company H1B Sponsorship • Vera Therapeutics, Inc. has a track record of offering H1B sponsorships, with 3 in 2025, 2 in 2024. Please note that this does not guarantee sponsorship for this specific role.