Manager, GxP Training & Quality Assurance

Mirum focuses on finding and developing drugs for difficult-to-treat liver diseases. Our programs are focused on cholestatic liver disease in children and adults.  Our drug candidates, maralixibat and volixibat, target the bile acid accumulation from cholestasis, and we believe our approach can address the underlying cause of symptoms, liver damage, and clinical outcomes. Our goal is to give families their lives back.

POSITION SUMMARY

The Manager of GxP Training is responsible for developing and managing activities involving GxP Training and compliance with applicable regulatory requirements, as well as the development and implementation of policies and procedures to ensure Mirum’s GxP Training program is in compliance with relevant regulatory and quality guidelines.

This position requires experience with, and knowledge of, local, state, and global (GxP) regulations. This position is responsible for identifying and driving continuous process improvement for the GxP portion of the LMS.

JOB FUNCTIONS/RESPONSIBILITIES

  • Assist the implementation team with the development and execution of the LMS to fully utilize the LMS for GxP Training.
  • Works directly with Department Managers to establish GxP training plans and curricula.
  • Backup to Business Owner with the coordination and maintenance of LMS end user accounts, permissions, and access rights.
  • Run metrics and verification reports for GxP employees in the LMS.
  • Administer/maintain all electronic GxP training files: individual (active and inactive) and group/classroom training (topic-specific) to maintain current and up-to-date reporting.
  • Assists with the planning and scheduling of the LMS roll out, releases, and upgrades.
  • Helps define business requirements to develop, implement, and improve GxP training solutions.
  • Will additionally perform senior Document Control activities, to support the Document Control department, as needed.
  • Prepares end-user training documentation to support LMS functionality.
  • Participates in LMS change management and audit process.
  • Manage the LMS specific curricula for GxP Functional Groups.
  • Works with management to develop and maintain annual GxP Training schedule.
  • Works with Functional Group leads to create and evaluate training curricula.
  • Performs other duties as assigned.

QUALIFICATIONS (Education/Experience):

  • Bachelor’s Degree.
  • 5+ years of experience in the pharmaceutical industry, directly related to managing GxP Training records.
  • Knowledge and demonstrated experience in the creation and maintenance of a compliant GxP Training Program (paper and electronic).
  • 5+ years of experience implementing and maintaining an LMS.
  • 5+ years of experience performing senior-level Document Control activities in an EDMS.
  • Previous experience implementing and managing ComplianceWire and Veeva QualityDocs strongly preferred.
  • Strong verbal and written communication skills.

To apply, please send your resume to careers@mirumpharma.com.