Title: Associate Director, Quality Assurance – Medical Device/Combination Product Location: Brisbane, California About Us: Vera Therapeutics (Nasdaq: VERA) is a late-stage biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients.
Position Summary: The Associate Director, Quality Assurance will report to the Senior Director, Quality Assurance and 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. Exceptional organizational, communication, and interpersonal skills are essential for effectively conveying quality requirements to stakeholders across various functions.
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 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, review, and approval 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. Ensure 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.Qualifications: 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 with CMOs is a plus.Excellent communication and interpersonal skills in working across the organization.Ability to operate in alignment with Vera's Core Values.Vera Therapeutics Inc. is an equal-opportunity employer.
#J-18808-Ljbffr