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← Vera Therapeutics, Inc.

Director, Quality Assurance, Combination Products

Vera Therapeutics, Inc.
Location
Remote
Posted
13 days ago
Department
Quality
What they actually want (must-haves)
  • 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
  • Experience in quality oversight of design controls and combination products
  • 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
Nice to have
  • Advanced degree preferred
  • Experience with quality oversight of biological drug products and working CMOs
What the job really is

The Director of Quality Assurance for Combination Products at Vera Therapeutics will oversee quality and compliance for combination product projects from inception through commercialization. This role involves developing quality strategies, collaborating with cross-functional teams, and ensuring adherence to regulatory standards. The position requires effective communication with stakeholders and participation in regulatory audits, while also providing oversight for validation studies conducted by external partners.

Benefits
  • Base pay range of $170,000 — $250,000 USD
  • Annual performance incentive bonus
  • New hire equity and ongoing performance-based equity
  • Medical, dental, and vision insurance
  • 401k match
  • Flexible time off
Things to weigh
  • Availability for 5-15% travel, both domestically and internationally
  • No specific mention of remote work policies beyond the stated location
  • Exact base pay depends on various factors, which may lead to variability in compensation
Job score3.2/5
Benefits4/5
Freshness4/5
Career value4/5
Role clarity4/5
Pay transparency0/5

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