Vera Therapeutics, Inc. · 8 hours ago
Director, Quality Assurance – Combination Products
United States
Full-time
Remote
Director/Executive
$170K/yr - $235K/yr
10+ years expVera 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 combination product projects, ensuring they meet regulatory standards while collaborating with cross-functional teams and external partners.
BiotechnologyHealth Care
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
Qualification
Required
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
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
Preferred
Advanced degree preferred
Experience with quality oversight of biological drug products and working CMOs in a plus
Company
Vera Therapeutics, Inc.
Vera Therapeutics, Inc.
201-500 employees
H1B Sponsorship
Vera Therapeutics, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (2)
Funding
Current Stage
Public CompanyTotal Funding
$1.23BKey Investors
Oxford Finance LLCAbingworth
2025-12-09Post Ipo Equity· $261M
2025-06-03Post Ipo Debt· $75M
2024-10-28Post Ipo Equity· $300M
Leadership Team
David L. Johnson
Chief Operating Officer
Kerry Cooper
Senior Vice President Medical Affairs
Recent News
2026-01-16
2026-01-11
The Motley Fool
2026-01-08
Company data provided by crunchbase