Vera Therapeutics, Inc | Associate Director, Analytical Quality Assurance | Brisbane
vor 2 Wochen
Title: Associate Director, Analytical Quality Assurance
Location: 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 fully humanized fusion protein self-administered at home as a subcutaneous injection once weekly that blocks both B-cell Activating Factor (BAFF) and A Proliferation Inducing Ligand (APRIL), which stimulate B cells and plasma cells to produce galactose-deficient IgA1 (Gd-IgA1) and associated autoantibodies, which together form immune complexes that are fundamental in the pathogenesis of IgA nephropathy (IgAN).
Vera is also considering evaluating the role of atacicept in other immunologic disorders.
Additionally, Vera is 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: .
Position Summary:
We are looking for an experienced Pharmaceutical Quality Assurance professional to provide oversight of analytical testing activities for sterile combination products.
This role will report to the Sr. Director of GMP Quality Assurance.
The ideal candidate will be detail-oriented, self-motivated, and capable of adapting to changing priorities while effectively managing workloads to meet project deadlines.
Responsibilities:
Provide Quality oversight of analytical method transfers and qualification/validation such as review and approve testing protocols, method validations, and reports for accuracy and compliance.
Provide Quality oversight of product release and stability testing.
Manage quality oversight for products manufactured, released, and tested at CMOs/CLOs.
Ensure CMOs and CLOs comply with regulatory standards, company requirements, and Quality Agreements.
Provide Quality oversight of out-of-specification (OOS), deviations and investigations, ensuring corrective and preventive actions (CAPAs) are implemented both at CMOs/CLOs and internally.
Evaluate CMO Change Requests and contribute to the design, development, and continuous improvement of Quality Assurance systems and programs to support quality activities at CMOs/CLOs and within Vera.
Participate in preparation for and execution of regulatory audits.
Ensures audit observations related to functional area are addressed appropriately and completed on schedule.
Act as the Quality representative on assigned product teams to advocate compliance and quality assurance.
Contribute to the definition and implementation of quality standards, specifications, methods, systems, and metrics for both clinical and commercial quality operations.
Lead or collaborate with cross-functional project teams to achieve both quality and business objectives.
Support product release and manage product complaint processes.
Available for 5-15% travel, both domestically and internationally, as required.
Qualifications:
Minimum of BA/BS degree.
8+ years of experience in quality oversight of analytical method transfer, qualification, and validation, or in a comparable role.
Strong knowledge of current Good Manufacturing Practices (cGMP) regulations and industry standards.
Experience in Quality System, specifically generation/revision of SOPs.
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.
Strong problem-solving skills, with a demonstrated ability to innovate and influence peers to achieve quality objectives.
In-depth familiarity with biologics product testing and ICH guidelines for analytical methods is required.
Vera Therapeutics Inc. is an equal-opportunity employer.
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