Senior Manager, Quality Assurance

🕒 April 21

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Vera Therapeutics, Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

🧬 Biotechnology

💊 Pharmaceuticals

Biotechnology • Pharmaceuticals

Vera Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for immunological kidney diseases that improve patients’ lives. The company is advancing Atacicept through clinical development for IgA nephropathy (IgAN), running Phase 2b and Phase 3 trials, and pursuing programs in lupus nephritis and other immunologic conditions. Headquartered in Brisbane, CA, Vera emphasizes science-driven drug development, patient engagement, and sustainability.

📋 Description

• Responsible for quality oversight of biologics sterile drug product (DP) manufacturing and combination products, including design control and Design History File (DHF) requirements. • Responsible for implementing strategies and tactics to promote and maintain GxP compliance. • Lead quality aspects of and provide quality support on DP 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 commercial and clinical DP/ combination products. • 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. • Review and approve validation protocols and reports such as process validation, shipping validation, cleaning validation, etc. • Provides assistance 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. • Lead for Quality Agreement with external partners. • Support product lifecycle and continued process verification. • Availability for 10-20% travel, both domestically and internationally.

🎯 Requirements

• Bachelor’s degree in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field. Advanced degree preferred. • Minimum 10+ years of experience in a GMP Quality, Compliance, and/or Regulatory setting. • Minimum 6+ years in a GMP QA role, with a preference for direct experience in biologics sterile DP manufacturing/aseptic processing including vials and prefilled syringes/autoinjectors. • 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. • 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. • 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. • Familiar with global medical device/combination products standards such as 21 CFR Parts 803, 806, and 820, ISO 13485, and EU MDR is a plus.

🏖️ Benefits

• Health insurance • 401(k) matching • Flexible work hours • Paid time off