Associate Director, Quality Assurance – Combination Products
Vera Therapeutics, Inc.
full-time
Posted on:
Location Type: Remote
Location: Remote • California • 🇺🇸 United States
Visit company websiteSalary
💰 $175,000 - $200,000 per year
Job Level
Senior
About the role
- 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 product, in alignment with company goals and regulatory requirements.
- Act as the QA contact for all quality-related inquiries and issues concerning device and combination product.
- 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, and review and approve 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 their 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.
- 8+ 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.
Benefits
- Health insurance
- Professional development opportunities
- flexible work arrangements
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality oversightdesign controlscombination productsrisk managementvalidationregulatory compliancequality strategiesproduct documentationaudit preparationbiological drug products
Soft skills
communicationinterpersonal skillsproblem-solvingcollaborationleadership
Certifications
Bachelor’s degreeadvanced degree (preferred)