Title: Associate Director, Quality AssuranceLocation: Brisbane, CA 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 fusion protein self-administered as a subcutaneous injection once weekly that blocks both B lymphocyte stimulator (BLyS) and a proliferation inducing ligand (APRIL), which stimulate B cells and plasma cells to produce autoantibodies contributing to certain autoimmune diseases, including IgA nephropathy (IgAN), also known as Berger's disease and lupus nephritis. In addition, Vera is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove medically useful. Vera is also 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:We seek an Associate Director, Quality Assurance to join an experienced, fast-paced and collaborative team. The Associate Director, Quality Assurance will report to the SVP, Regulatory Affairs & Quality Assurance and will be responsible for developing and maintaining GMP, GLP and GCP Quality Management Systems in accordance with FDA, ICH, EMA regulations and guidelines and industry standards. The Associate Director, Quality Assurance will build an internal team and relationships with external consultants/contractors, as necessary to support QA activities and responsibilities and provide leadership and guidance to the organization on global quality matters.Responsibilities:Develop and maintain Quality Management Systems in compliance with quality standards and guidelines set by regulations and per industry standards.Assess and assure quality and regulatory compliance related to GCPs, pharmacovigilance, GLPs, and other related activities performed by employees and vendors.Provide QA for GMP, GLP, GCP environment(s) and Document Control.Manage the investigation and resolution of Out of Specifications and Deviations.Establish or develop GXP policies and/or procedures (e.g., SOPs, work instructions).Perform other duties and responsibilities as the company may assign from time to time, including non-Quality assignments, as required.Develop and run Quality Governance meetings: Management Review, Quality Council.Qualifications:Bachelor's Degree or higher in biology, chemistry, or related life-sciences discipline.Pharmaceutical Industry experience: 8+ years in Quality, including demonstrated leadership in a QA function.Prior experience establishing, implementing and administrating quality systems, including Electronic Document Management Systems (EDMS). Veeva Qdocs and QMS modules experience a plus.Ability to lead Quality governance meetings to oversee systems and drive issue resolution.Experience leading deviations and investigations into complex quality issues.Experience in change control, product complaints, CAPAs.Demonstrated understanding of GxP requirements, regulations, development processes and regulatory inspection procedures.Demonstrated creativity, problem solving, critical analysis, initiative, judgment and decision-making skills.Flexibility in prioritizing work and ability to thrive in a rapidly changing environment.Strong ability to work within a team environment and professionally represent Vera to various external stakeholders.Excellent interpersonal, written, and oral communication skills.Must be able to travel domestically and internationally.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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