Associate Director, Quality Assurance
2 days ago
Vera Therapeutics is seeking a highly experienced Associate Director, Quality Assurance to oversee the quality assurance for biologic/device combination product projects from inception to commercialization. The ideal candidate will have a strong background in drug delivery systems and medical device regulations.
Key Responsibilities:
- Oversee the quality and compliance of medical device combination products, ensuring they meet regulatory standards and company objectives.
- Develop and implement quality strategies and processes for medical device combination products, in alignment with company goals and regulatory requirements.
- Act as the main contact for all quality-related inquiries and issues concerning medical device combination products.
- Conduct regular audits and inspections to ensure compliance with applicable regulations, standards, and company policies.
- 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 device/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 regulations and industry best practices, and proactively identify potential compliance risks and solutions.
- Develop and deliver training programs to ensure all employees involved in the development and manufacturing of medical device combination products are knowledgeable about quality and compliance requirements.
- Participate in the development, and review and approve of product documentation, including design control, risk management, and validation protocols.
- Collaborate with external partners and suppliers to ensure their quality and compliance with company standards.
- Communicate effectively with senior management to provide updates on the status of quality and compliance for medical device combination products.
- 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 for 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 the pharmaceutical or medical device industry is highly preferred.
- In-depth knowledge of global medical device regulations such as 21 CFR Parts 803, 806, and 820, ISO 13485, and EU MDR.
- Familiar with combination product lifecycle management from initial design phase to commercialization.
- Experience with biological drug products and working CMO in a plus.
- Excellent communication and interpersonal skills in working across the organization.
- Ability to operate in alignment with Vera's Core Values.
Vera Therapeutics is an equal-opportunity employer. We offer a competitive compensation package, including base pay, annual performance incentive bonus, new hire equity, and ongoing performance-based equity. We also offer various benefits, including medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.
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