Senior Manager, Quality Assurance

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Vera Therapeutics’ mission is to advance treatments that target the source of disease in order to change the standard of care for patients. Vera Therapeutics’ 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 (IgAN) and lupus nephritis. Beyond IgAN, Vera Therapeutics is evaluating additional diseases where the reduction of autoantibodies by atacicept may prove clinically meaningful. In addition, Vera Therapeutics holds an exclusive license agreement with Stanford University for a novel, next generation fusion protein targeting BAFF and APRIL, known as VT-109, with wide therapeutic potential across the spectrum of B-cell–mediated diseases. Vera Therapeutics is also evaluating the development of MAU868, a monoclonal antibody designed to neutralize infection with BK virus, which can have devastating consequences in kidney transplant recipients. Vera Therapeutics retains all global developmental and commercial rights to atacicept, VT-109, and MAU868. 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 Senior Manager, Quality Assurance, Drug Product focus, will report to the Director, Quality Assurance. The Senior Manager is responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Products and Devices meet regulatory requirements and internal Vera standards. Responsibilities: Responsible for quality oversight of biologics sterile drug product (DP) manufacturing and combination products, including design control and Design History File (DHF) requirements. Responsible for implementing strategies and tactics to promote and maintain GxP compliance. Lead quality aspects of and provide quality support on DP tech transfers. 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 material disposition of commercial and clinical DP/ combination products. Review executed batch records and associated documentation for material disposition. Review and approve GMP documentation such as master batch records, deviations, change controls, specifications, and various other protocol and reports to support GMP production. Review and approve validation protocols and reports such as process validation, shipping validation, cleaning validation, etc. Provides assistance during both internal and regulatory agency audits as required Perform Person-in-Plant duties, 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 Agreement with external partners. Support product lifecycle and continued process verification. Availability for 10-20% travel, both domestically and internationally. Qualifications: Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred. Minimum 10+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting. Minimum 6+ years in a GMP QA role, with a preference for direct experience in biologics sterile DP manufacturing/aseptic processing including vials and prefilled syringes/autoinjectors. Excellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and among external collaborators. Innovative skills with problem solving and peer influence. In-depth knowledge of FDA, ISO, EMA, GMP and ICH quality systems and regulatory requirements. Experience of working with external partners. Strong attention to detail is a must. Excellent interpersonal, written and oral communication skills. Outstanding organizational skills. Ability to operate in a fast-paced, multi-disciplinary industrial environment. Capable and comfortable with normally receiving no instructions on routine work and general instructions on new assignments. Familiar with global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and EU MDR is a plus. 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 $127,000—$193,000 USD Notice to Recruiters/Staffing Agencies Recruiters and staffing agencies should not contact Vera Therapeutics through this page. All recruitment vendors (search firms, recruitment agencies, and staffing companies) are prohibited from contacting our hiring manager(s), executive team members, or employees. We require that all recruiters and staffing agencies have a fully executed, formal written agreement on file. Vera Therapeutics’ receipt or acceptance of an unsolicited resume submitted by a vendor organization to this website or employee does not constitute an actual or implied contract between Vera Therapeutics and such organization and will be considered unsolicited and Vera Therapeutics will not be responsible for related fees. Fraud Alert To all candidates: your personal information and online safety are a top priority for us. At Vera Therapeutics, recruiters only direct candidates to apply through our official career page at https://veratx.com/careers/. Recruiters will always contact you using the domain of veratx.com. We will never request payments, ask for financial account information or sensitive information like social security numbers. If you are unsure if a message is from Vera Therapeutics, please email human resources.