Senior Manager, Quality Management System

Job Summary

To support the development and commercialization of innovative cell therapies, the full-time Senior Manager, Quality Management System will manage and enhance Quality Systems, ensuring compliance with US, EU, and ICH requirements in a remote work environment.

Key responsibilities

• Manage processes, SOPs, and workflows for core QMS programs, including Deviations, Investigations, CAPA, and Change Control
• Lead the implementation and optimization of the electronic Quality Management System (eQMS) while ensuring data integrity and compliance
• Monitor QMS effectiveness, identify gaps, and drive continuous improvement initiatives across cross-functional teams

Required qualifications

• Bachelor's degree in Computer Science, Life Sciences, or a related field, or equivalent relevant experience
• Minimum of 8 years of experience in the pharmaceutical or biotechnology industry, with at least 6 years in Quality Systems / Quality Assurance
• Demonstrated experience implementing and improving an eQMS, including system configuration and validation support
• Strong working knowledge of quality system data management and reporting principles
• Proven ability to manage deviations, investigations, CAPAs, and change controls in a regulated environment