Senior Manager, Quality Assurance

Responsibilities

• Oversee quality and compliance for cell bank and biologics drug substance (DS) manufacturing
• Implement strategies and tactics to promote and maintain GxP compliance
• Provide quality support for technology transfers and various validations (process, shipping, cleaning, etc.)
• Liaise with CMO Quality partners to communicate QA policies and procedures
• Collaborate with contract manufacturers and internal stakeholders to address deviations, investigations, and compliance issues
• Manage material disposition for cell banks, as well as clinical and commercial drug substances
• Review and approve GMP documentation, including master batch records, deviations, change controls, and specifications
• Support internal and regulatory agency audits and perform Person-in-Plant duties as required
• Act as the Quality representative on assigned product teams to advocate for compliance
• Participate in Quality Agreement negotiations with external partners

Requirements

• Bachelor's degree with 10+ years of experience or a Master's degree with 7+ years in biomedical engineering, chemical engineering, pharmaceutical sciences, or a related field
• Minimum 6+ years of experience in a GMP Quality, Compliance, or Regulatory setting
• Minimum 6+ years in a GMP QA role
• In-depth knowledge of FDA, ISO, EMA, GMP, and ICH quality systems and regulatory requirements
• Experience working with external partners and biologics drug substance manufacturing
• Strong attention to detail and excellent organizational skills
• Ability to travel 5-15% domestically and internationally

Preferred Qualifications

• Direct work experience in Manufacturing or Quality Control (QC)
• Experience working specifically with Cell Banks
• Experience with process validation

About the Company

Vera Therapeutics is a biotechnology company focused on developing treatments for serious immunological diseases. Our mission is to advance treatments that target the source of disease in order to change the standard of care for patients.