Foster City

POSITION SUMMARY 

Manages activities involving GxP quality assurance and compliance with applicable regulatory requirements. Assists in the development of policies and procedures to ensure quality standards in compliance with relevant regulatory and quality guidelines. This position requires experience with global contract manufacturing organizations and knowledge of global GxP regulations. The incumbent provides strategic direction of Mirum’s Quality Management System to ensure execution and performance of the QMS in accordance with regulatory requirements and company objectives.

JOB FUNCTIONS/RESPONSIBILITIES

• Assist with the overall management of Mirum’s GxP vendor qualification and audit program. Assist with audit scheduling, report reviews, tracking and trending vendor management activities and CAPA follow up.
• Assist with the establishment of vendor performance KPIs and reporting structure.
• Assist with the implementation of a Supplier Scorecard structure.
• Assistance with the global Alliance Management qualification process.
• Assistance with hosting and conducting Partner audits.
• Ensures that the Quality Management System is maintained in accordance with current regulatory compliance requirements and meets company objectives.
• Author quality policies and standard operating procedures, as needed.
• Establish and oversee the processes for accurately tracking, reporting, and analyzing metrics, as required.
• Assist with audits and regulatory inspections, as applicable.
• Update/establish Quality/Technical Agreements with CMOs. Assist with the tracking of Quality Agreements.
• Support GxP inspection readiness activities.
• Other duties assigned, as needed.

QUALIFICATIONS

Education/Experience:

• Bachelor’s degree in a scientific discipline

Knowledge, Skills and Abilities:

• 4-6 years’ experience and strong background in Quality and Quality Systems in the drug development industry with knowledge of GxP/ICH/FDA/EMA regulations.
• Prior experience in QA with particular focus vendor management, auditing and supplier performance initiatives.
• Experience with working in a global setting and a thorough understanding of international regulatory requirements.
• Demonstrate a quality mindset and ability to influence across the organization.
• Successful experience writing and reviewing SOPs and other Quality documents.
• Expert knowledge of phase appropriate cGxPs and experience leading Quality System implementation and continuous improvement efforts.
• Demonstrated ability to successfully interact with regulatory health authorities at inspections and thorough understanding of audit and vendor management programs.
• 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 electronic quality management system is a plus.

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