Specialist, Vendor Compliance

Role Summary

The Specialist, Vendor Compliance manages Mirum’s vendor management program activities, including tracking and trending vendor management data, vendor audit management, CAPA follow-up, and capturing metrics related to vendor management. The role supports SOP revisions to sustain the organization and assists with maintaining the eQMS system as it relates to vendor and audit management.

Responsibilities

• Assist with the overall management of Mirum’s GxP vendor qualification and audit program.
• Perform the day-to-day activities of the vendor qualification and audit program, including audit scheduling, report reviews, response review, CAPA follow-up, and audit close-out.
• Create, manage, and administer the process for vendor management in the eQMS system and conduct routine tasks, as needed.
• Assist with the authoring of quality policies and standard operating procedures, as needed.
• Gather data for accurate tracking, reporting, and analyzing metrics, as required.
• Assist with internal/external audits and regulatory inspections, as applicable.
• Support GxP inspection readiness activities, as applicable.

Qualifications

• 1-3 years’ experience in Quality and GxP Vendor Management/Audit Processes in the drug development industry with knowledge of cGMP/ICH/FDA/EMA regulations
• Prior experience in QA with particular focus on managing vendor qualification related activities.
• Demonstrate a quality mindset and ability to influence across the organization
• Exposure to writing and reviewing SOPs and other quality documents. General understanding of quality systems that support internal GxP activities for pre-clinical, clinical and commercial products.
• Excellent organizational skills: Proactive, management of multiple tasks of varying complexity simultaneously
• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication are essential in this collaborative work environment.
• Experience with Veeva platform system is a plus

Education

• Bachelor’s degree in a scientific discipline