Director, Quality Assurance, Combination Products
Benefits
Unlimited PTO
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Role Overview:
- Lead quality assurance for combination products from design through commercialization.
- Act as the QA representative on product teams, advocating compliance and quality.
Key Responsibilities:
- Collaborate with product development, manufacturing, clinical, and regulatory teams.
- Provide QA oversight for external partners and validation studies.
- Drive closure of gaps in Design History File and Risk Management.
Qualifications:
- 10+ years of experience in quality oversight of drug-device development.
- In-depth knowledge of 21 CFR Parts 803, 806, 820, ISO 13485, ISO 14971, and EU MDR.
Compensation & Benefits:
- Anticipated base pay range of $170,000 - $250,000 USD.
- Eligible for annual performance bonus, equity, and comprehensive benefits.
Vera Therapeutics
Vera Therapeutics is a commercial-stage biotechnology company focused on transforming medicine in autoimmune disease, starting with the kidney. Founded in 2016 and based in Brisbane, California, the company fosters a culture of empathy, urgency, and an owner's mindset.