Senior Manager, Quality Assurance

Senior Manager, Quality AssuranceBrisbane, CA Vera Therapeutics is a commercial-stage biotechnology company focused on the pursuit of truth in science to transform medicine in autoimmune disease, starting with the kidney. Vera Therapeutics is evaluating multiple diseases where the reduction of autoantibodies through inhibition of BAFF and APRIL may prove clinically meaningful. Vera Therapeutics was founded in 2016 and is based in Brisbane, California. To learn more, visit At Vera, our values are the cornerstone of our culture and guide how we work together every day. We lead with empathy, act with an owner's mindset, demand clarity, work without fences, and execute with urgency because patients are counting on us. From how we hire and develop our people to how we advance rigorous science, we are building a team committed to transforming medicine in autoimmune diseases, starting with the kidney.Position Summary:The Senior Manager, Quality Assurance (QA), will report to the Director, QA Drug Substance and is primarily responsible for QA function for Cell Bank and Drug Substance (DS). The position is responsible for collaborating with cross-functional teams and external partners to ensure both clinical and commercial Drug Substances meet regulatory requirements and internal Vera standards.Responsibilities:Support the oversight of the quality and compliance, primarily cell bank and biologics DS manufacturing.Support implementation of strategies and tactics to promote and maintain GxP compliance.Provide quality support on 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 cell banks, commercial and clinical DS.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.Provide quality support for validations including process validation, shipping validation, cleaning validation, etc.Provides support 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.Participate in Quality Agreements negotiation with external partners.Support product lifecycle and continued process verification.Availability for 5-15% travel, both domestically and internationally.Qualifications:Bachelor's degree with 10+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field or a Master's degree with 7+ years of experience in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field.Minimum 6+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting.Minimum 6+ years in a GMP QA role, and preferably direct work experience in either Manufacturing or QC, as well.Excellent written and verbal communication skills, including 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 and biologics DS manufacturing.Experience working with Cell Bank is a plus.Experience with process validation is a plus.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.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$140,000 - $190,000 USDAt 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.