Associate Director, Quality System, QMS

Role: Lead the implementation and oversight of Veeva QMS modules within Mirum Pharmaceuticals, ensuring compliance with global regulatory standards and enhancing quality management systems. Responsibilities: manage system configuration, validation, and deployment; develop and maintain policies, SOPs, and training; collaborate with cross-functional teams (Quality Assurance, Manufacturing, Supply Chain, IT); monitor system performance and drive continuous improvement; support audits and inspections. Qualifications: Bachelor’s degree in a scientific discipline; 12+ years in Quality/QMS within drug development; deep knowledge of cGMP/ICH/FDA/EMA regulations; experience with electronic QMS platforms, ideally Veeva Vault QMS; strong project and change management skills; proven ability to influence organizational processes and lead quality system initiatives. HighValue: extensive QMS expertise (particularly Veeva Vault), regulatory inspection readiness, cross-functional collaboration, and process standardization. WorkSetup: not specified; likely hybrid or onsite based on typical GMP environments.