Vera Therapeutics (Nasdaq: VERA), is a late clinical-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 fusion protein self-administered at home as a subcutaneous once weekly injection that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy. Vera is also evaluating the role of atacicept in other immunologic disorders. Additionally, Vera is developing VT-109, a novel, next-generation dual BAFF/APRIL inhibitor in preclinical development, and 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.

The Associate Director, Quality Assurance (QA) will report to the Senior Director of QA and will lead the QA function related to packaging and labeling of commercial and clinical finished products release, management of product complaints, and preparation of Annual Product Reviews (APRs). The Associate Director is responsible for collaborating with cross-functional teams and external partners to ensure finished product releases, product complaints and APRs meet regulatory requirements and internal Vera standards.

Responsibilities:

Lead QA oversight for finished product release and distribution activities in compliance with cGMP and GDP requirements. Review and approve batch documentation and quality documentation to support timely release of finished product. Serve as QA point of contact for CMOs, contract testing labs, and distribution partners. Responsible for implementing strategies and tactics to promote and maintain GxP compliance. Liaise with CMO Quality partners to communicate QA policy and procedures. Collaborate with contract manufacturers and internal stakeholders to address deviations/ investigations and compliance issues. Responsible for managing product complaints. Responsible for commercial product annual product quality review. Review and approve GMP documentation including master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production. Provides assistance during both internal and regulatory agency audits as required. Participate in Material Review Board as required. Helps define and implement appropriate quality standards/specification, methods, systems, and metrics for clinical and commercial quality operations. Act as the Quality representative on assigned product teams to advocate compliance and quality assurance. Lead for Quality Agreements with external partners. Support product lifecycle and continued process verification. Manage one (1) direct report. Availability for 5-10% travel. Qualifications: Bachelor's degree in Life Sciences, Engineering, Chemistry, or a related field (advanced degree preferred). Minimum of 8 years of Quality Assurance experience within the biotechnology or pharmaceutical industry, including at least 3 years in a leadership role. Strong working knowledge of cGMP, GDP, FDA, EMA, and ICH regulatory requirements. Demonstrated experience overseeing commercial product finished product release, Qualified Person interaction and complaint handling. Proven track record in managing Annual Product Reviews (APRs). Excellent problem-solving, communication, and leadership abilities. Outstanding written and verbal communication skills, with the ability to effectively collaborate within project teams, cross-functionally, and with external partners. Innovative mindset with strong peer influence and problem-solving skills. In-depth understanding of FDA, ISO, EMA, GMP, and ICH quality systems and regulatory standards. Experience working with external partners and vendors. Exceptional attention to detail. Strong interpersonal, organizational, and communication skills. Ability to thrive in a fast-paced, multi-disciplinary industrial environment. Self-motivated and capable of working independently, often with minimal supervision on routine tasks and with clear guidance on new assignments.

Vera Therapeutics Inc. is an equal-opportunity employer.

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.

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. 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.

For this role, the anticipated base pay range is

$175,000-$192,000 USD

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