Job Details

Senior Manager, Quality Assurance Analytical

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-cellmediated 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.

Our values are the cornerstone of our culture. Our values inspire us every day and guide everything we dofrom 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 Analytical will report to the Director, Quality Assurance Analytical and will be responsible for all aspects of Analytical Method validation, verification and transfer, including stability programs, change control and deviations. Working with the CMC team and key personnel including Regulatory, Project Management, and with external CDMO and Contract Testing Laboratories, this position will ensure timely delivery of investigational products, drive process/product understanding and enable commercial supply. The successful candidate will be detail-oriented, self-directed and possess the ability to be flexible and manage workloads to meet project timelines.

Responsibilities:

• Provide 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, ensure 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.

Qualifications:

• Bachelor's degree in Life Sciences, Engineering, Quality, or related discipline. Advanced degree preferred.
• Minimum of 7 years Quality Assurance experience within the pharmaceutical/biotech industry in quality oversight of analytical method transfer and validation or equivalent across multiple technical areas (chromatography, bioassays, microbiological, etc.).
• Strong knowledge of cGMPs and with international regulatory guidelines for analytical methods and stability studies.
• Experience working with CDMOs and CTLs.
• Experience in Quality System, specifically deviation, change controls and generation/revision of SOPs.
• Excellent communication and interpersonal skills in working across the organization and external partners.
• Ability to operate in alignment with Vera's Core Values.

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 $145,000 - $175,000 USD