Associate Director, Quality Assurance - Combination Products

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. Vera’s mission is to advance treatments that target the source of immunologic diseases in order to change the standard of care for patients. Vera’s lead product candidate is atacicept, a fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN). Vera is also considering evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing MAU868, a monoclonal antibody designed to neutralize infection with BK Virus, a polyomavirus that can have devastating consequences in certain settings such as kidney transplant. For more information, please visit: www.veratx.com.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we do—from how we hire great people, to advancing our mission together, to achieving our ultimate goal to improve medical treatment for patients suffering from immunological diseases.

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. This role will involve collaboration with cross-functional teams to ensure that the combination product meets regulatory standards, are safe and effective for patient use.

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.

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 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 Inc. is an equal-opportunity employer.

Vera Therapeutics is committed to fair and equitable compensation practices and we strive to provide employees with total compensation packages that are market competitive. For this role, the anticipated base pay range is $170,000 - $208,000. The exact base pay offered for this role will depend on various factors, including but not limited to the candidate’s geography, qualifications, skills, and experience.

At Vera, base pay is only one part of your total compensation package. The successful candidate will be eligible for an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Vera Therapeutics also offers various benefits offerings, including, but not limited to, medical, dental, and vision insurance, 401k match, flexible time off, and a number of paid holidays.

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