About the job
Vera Therapeutics is a pioneering biotechnology firm dedicated to developing innovative treatments for severe immunological disorders. Our mission is to revolutionize patient care by advancing therapies that target the underlying causes of diseases. Our flagship product, atacicept, is a game-changing fusion protein that can be self-administered at home through a once-weekly subcutaneous injection. It effectively inhibits B-cell Activating Factor (BAFF) and A Proliferation-Inducing Ligand (APRIL), which are crucial in the production of autoantibodies linked to autoimmune conditions such as IgA nephropathy (IgAN) and lupus nephritis. In addition to IgAN, we are exploring other diseases where atacicept’s ability to reduce autoantibodies may significantly impact clinical outcomes. We also have an exclusive licensing agreement with Stanford University for a next-generation fusion protein, VT-109, with broad therapeutic implications across various B-cell-mediated diseases. Furthermore, we are investigating MAU868, a monoclonal antibody aimed at neutralizing BK virus infections, which can be severely detrimental to kidney transplant recipients. Vera Therapeutics holds all global developmental and commercial rights to atacicept, VT-109, and MAU868. To learn more, visit www.veratx.com.
Our core values form the foundation of our culture, inspiring us daily and guiding our efforts, from recruitment to mission advancement and ultimately enhancing medical treatments for individuals suffering from immunological diseases.
Position Summary:
The Associate Director, GxP Systems, reporting to the Sr. Director of Commercialization Systems, will spearhead the implementation, validation, and support of GxP-regulated systems essential for Quality Assurance, Regulatory, Clinical, and Process Development & Manufacturing (PD&M) in a dynamic commercial biotech environment. This role is crucial in ensuring regulatory compliance and facilitating successful commercialization. Collaborating with Quality Assurance, Medical Affairs, Regulatory Affairs, Clinical Operations, and PD&M teams, the Associate Director will ensure that systems are validated, purpose-fit, and adaptable to evolving business needs.
