Senior Director, Quality Assurance
1 week ago
Company Overview:
Vera Therapeutics is a late-stage biotechnology company dedicated to developing innovative treatments for serious immunological diseases. With a mission to advance treatments that target the source of these diseases, Vera aims to change the standard of care for patients.
The company's lead product candidate, atacicept, is a fully humanized fusion protein self-administered as a subcutaneous injection once weekly. This treatment blocks 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. These immune complexes are fundamental in the pathogenesis of IgA nephropathy (IgAN).
In addition to atacicept, 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.
Job Summary:
The Senior Director, Quality Assurance will be responsible for leading the overall quality systems of the company's GxP activities. This critical role will design, prioritize, implement, monitor, and communicate Vera's GxP quality strategy and quality programs.
This position requires experience, knowledge, and leadership credibility to ensure compliance with Quality standards and corporate-wide commitment to Quality principles.
Key Responsibilities:
Design and prioritize GxP quality strategies and quality programsImplement and monitor GxP quality systemsCommunicate GxP quality strategies and quality programs to internal stakeholdersLead cross-functional teams to develop and implement GxP quality initiativesEnsure compliance with global regulatory requirements and industry standardsCollaborate with internal partners to identify and mitigate quality risksDevelop and maintain quality procedures and protocolsProvide training and support to internal teams on GxP quality policies and proceduresAnalyze and report on quality metrics and trendsIdentify areas for process improvement and implement changesQualifications:
The ideal candidate will have a BS or higher degree in a relevant technical discipline and 15+ years of experience in the biotechnology or pharmaceutical industry. The successful candidate will have demonstrated leadership experience and a thorough understanding of industry regulatory environments related to Quality Systems.
Compensation and Benefits:
We offer an attractive compensation package, including an estimated annual salary of $355,000, an annual performance incentive bonus, new hire equity, and ongoing performance-based equity. Our benefits offerings include medical, dental, and vision insurance, 401k match, flexible time off, and paid holidays.
About Vera Therapeutics:
Vera Therapeutics is an equal-opportunity employer committed to fair and equitable compensation practices. We strive to provide employees with total compensation packages that are market competitive. For more information about our company culture and values, please visit our website at veratx.com/careers.
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