Kyverna - Sr. Manager, Quality Management System (QMS)
Requirements
• Bachelor’s degree in Computer Science, Life Sciences, or a related field, or equivalent relevant experience. • Demonstrated experience implementing, administering, and improving an eQMS, including system configuration, validation support, and lifecycle management. • Minimum of 8 years of experience in the pharmaceutical or biotechnology industry, including 6+ years in Quality Systems / Quality Assurance. • Strong working knowledge of quality system data management, reporting, and data integrity principles. • First-hand experience managing and overseeing deviations, investigations, CAPAs, and change controls in a regulated environment. • Experience using validated computerized systems to manage regulated quality records. • Proven ability to develop and implement enhancements to eQMS to improve usability, compliance, and reporting. • Strong proficiency with Microsoft Office Suite and related business applications. • Ability to manage multiple priorities in a fast-paced, evolving environment with strong attention to detail. • Highly organized, self-motivated, and capable of working independently while effectively collaborating cross-functionally. • Excellent written and verbal communication skills, with the ability to influence and interact effectively at all levels of the organization.
Responsibilities
• Manage and maintain processes, SOPs, and workflows for Deviations, Investigations, CAPA, Change Control, Quality Metrics, and other core QMS programs. • Provide QA oversight of Information Technology systems supporting GxP processes. • Lead or support the implementation, configuration, validation, and optimization of the electronic Quality Management System (eQMS), ensuring phase-appropriate design and scalability. • Provide hands-on expertise in the day-to-day execution, review, and management of QMS records within the eQMS. • Partner with internal stakeholders to define data governance, system configuration, user roles, and reporting requirements for quality systems. • Ensure data integrity, traceability, and compliance of quality system data in accordance with regulatory expectations (e.g., ALCOA+ principles). • Monitor overall QMS effectiveness, identify gaps or inefficiencies, and drive continuous improvement initiatives. • Recommend updates to quality policies and procedures and implement process improvements aligned with organizational growth and regulatory readiness. • Develop, compile, analyze, and present quality metrics and KPIs for routine quality management review. • Perform trending and data analysis to identify risks, systemic issues, and opportunities for improvement. • Create and deliver training programs related to QMS processes, data integrity, and eQMS functionality. • Support inspection readiness and ensure adherence to cGMPs, regulatory mandates, and internal quality standards. • Build and maintain strong cross-functional relationships and foster a culture of engagement, transparency, and quality ownership.
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