Temporary Senior Manager, Quality Assurance

3 weeks ago

Brisbane, United States Vera Therapeutics Full time

Job DescriptionTitle: Temporary Senior Manager, 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 someone who has Pharmaceutical Quality Assurance experience to provide oversight of analytical testing activities (QA for QC) and sterile drug product primary packaging and secondary packaging into autoinjectors. The position will report to the Head of Quality and will be responsible for overseeing GMP activities for manufacturing of Vera's investigational products. The successful candidate will be detailed oriented, self-directed and with the ability to be flexible and manage workload to meet project timelines. Responsibilities: Provides Quality oversight of analytical method qualificationsProvide Quality oversight of sterile drug product manufacturing Support process performance qualification (PPQ) activities.Management of CMOs to ensure compliance to regulatory standards, company requirements and Quality AgreementWork with CMOs to ensure compliance to Quality SystemsResponsible for the Quality of the products manufactured, released and tested in the CMOs/CLOsEstablish CMO targets and ensure targets are metLot DispositionReview of production batch records, testing records and lot files for release and disposition of production batchesResolve cGMP deviations and investigations and assure appropriate corrective and preventive actions (CAPAs) are implemented at CMO and internallyAssessment of Change Requests from CMOsContribute in the design, development, implementation, maintenance and improvement of Quality Assurance systems and programs to support and manage quality activities at CMO and in the companyLead or participate in cross-functional project teams as necessary or appropriate to achieve quality and business goals Qualifications: Minimum of BA/BS degree preferred with 10 years in Quality Assurance Solid understanding of GMP regulations.Experience in sterile drug product filling and autoinjectors (medical device) preferredExperience in analytical methods QA oversightExcellent written and verbal communication skills, including a demonstrated ability to effectively communicate in a project team environment, within department, among functional groups and external collaboratorsInnovative with problem solving and peer influence skills Vera Therapeutics Inc. is an equal opportunity employer.Vera Therapeutics is committed to fair and equitable compensation practices, and we strive to be market competitive. The position pays a minimum of $120.00 an hour. The exact hourly pay offered for this role will depend on various factors, including but not limited to the candidate's geography, qualifications, skills, and experience.COVID-19 PolicyVera's top priority is the health and safety of our employees, their families and the communities where they live and work. As part of our commitment to health and safety, we require all U.S. employees to be fully vaccinated against COVID-19. If your role at Vera requires you to work or otherwise be on Vera's premises, full or part-time, we require our employees to comply with Vera's mandatory COVID-19 vaccination policy (currently requiring full vaccination). Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, may request a reasonable accommodation with Human Resources. Your employment is also subject to ongoing compliance with the mandatory vaccination policy and all other Vera policies, as they may be modified from time to time, at the sole discretion of Vera.Notice to Recruiters/Staffing AgenciesRecruiters 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.

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