Job Details

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases.Position SummaryThe Senior Manager, Quality Assurance Analytical reports to the Director, Quality Assurance Analytical. This role is responsible for all aspects of analytical method validation, verification and transfer, including stability programs, change control and deviations. Working with the CMC team, regulatory, project management, CDMOs and contract testing laboratories, this position ensures timely delivery of investigational products, drives process/product understanding and enables commercial supply.ResponsibilitiesProvide quality oversight for validation activities in a cGMP environment, ensuring compliance with industry standards.Review and approve release, in‑process and stability‑indicating procedures, validation protocols/reports, and change controls to maintain high‑quality assurance.Collaborate with contract manufacturing and testing labs to uphold GxP standards, fostering strong partnerships.Work virtually with external partners to develop and manage release testing and stability programs, ensuring compliance with regulatory guidelines.Review and approve CMC/CDMO/CTL related change controls, deviations, and OOS investigations.Review and approve reference standards and critical reagents qualifications for multiple CDMOs and CTLs.QualificationsBachelor's degree in Life Sciences, Engineering, Quality, or related discipline; advanced degree preferred.Minimum of 7 years of quality assurance experience within the pharmaceutical/biotech industry, overseeing analytical method transfer and validation across multiple technical areas (chromatography, bioassays, microbiological, etc.).Strong knowledge of cGMPs and international regulatory guidelines for analytical methods and stability studies.Experience working with CDMOs and CTLs.Experience in quality systems, specifically deviation, change controls and generation/revision of SOPs.Excellent communication and interpersonal skills.Ability to operate in alignment with Vera's Core Values.Vera Therapeutics Inc. is an equal‑opportunity employer.Salary range: $145,000 – $175,000 USD#J-18808-Ljbffr