Kyverna - Therapeutics - Sr. Manager, GxP Auditor (GCP & GMP)
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Requirements
• ASQ Certified Quality Auditor (CQA) or equivalent certification required • BA/BS in Biological Sciences, Chemistry, or a related field, or equivalent combination of education and experience • Minimum of 10+ years of experience in the pharmaceutical or biotechnology industry, including at least 5+ years in GMP, GCP, and/or GVP auditing • Strong working knowledge of GMP, GCP, GPV, and GLP regulations across U.S. and EU frameworks, including ICH guidelines • Demonstrated leadership capabilities with experience in people management and development • Excellent written and verbal communication skills, with strong organizational abilities • Willingness and ability to travel up to 25% to support audit activities • Proven ability to operate effectively in a fast-paced, high-growth environment with evolving priorities • Hands-on experience with Quality Systems and electronic databases (e.g., eQMS platforms) and clinical systems such as Veeva Vault/RIM, ARGUS, and Medidata • Proficiency in Microsoft Office Suite, including Excel, Outlook, PowerPoint, and Word • Experience in quality management within a GxP-regulated environment • Experience supporting cell and/or gene therapy products • Strong strategic thinking and project management skills • Direct experience leading or participating in regulatory inspections • Demonstrated ability to develop executive-level presentations and analyze complex datasets
Responsibilities
• Lead and execute internal audits across GMP, GCP, and GPV systems and associated functions, ensuring timely follow-up through CAPA implementation • Conduct GxP audits in accordance with applicable regulatory requirements, including preparation of detailed audit reports and oversight of corrective and preventive actions • Apply strong knowledge of clinical and CMC development processes to manage and continuously improve the internal GxP audit program • Independently manage multiple priorities, solve complex problems, and maintain a high level of inspection readiness • Support external audits and regulatory inspections, partnering closely with cross-functional teams • Represent Quality Vendor Management in cross-functional meetings, contributing to aligned and compliant decision-making • Oversee the GxP vendor and supplier management program to ensure compliance with regulatory standards and internal requirements • Perform risk assessments and drive continuous improvement initiatives to strengthen quality and compliance frameworks • Author, review, and update SOPs to ensure alignment with evolving regulatory expectations and business needs • Develop and implement tools and processes to enhance audit consistency, efficiency, and overall compliance • Support inspection readiness activities and collaborate with stakeholders to ensure organizational preparedness • Ensure supplier management processes, including qualification and ongoing oversight, are executed in accordance with SOPs and KPIs • Support the development and maintenance of Quality Agreements and supplier contracts as needed • Escalate critical findings to appropriate management and ensure timely and effective resolution in line with company procedures • Lead the development and monitoring of supplier performance metrics to proactively identify risks and mitigate compliance issues • Maintain and manage the approved supplier list to ensure accuracy and compliance
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