Associate Director, Quality System, QMS

Company

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important medicines for rare disease patients.

Leads roll out and oversight of Veeva QMS modules, ensuring compliance with applicable regulatory requirements. Manages the development, implementation, and continuous improvement of policies and procedures to maintain quality standards aligned with global regulatory and company guidelines. Partners cross-functionally to ensure effective execution of quality processes. Applies strong knowledge of global regulations to support compliant and efficient operations. Contributes to the strategic direction and ongoing performance of the Quality Management System (QMS), driving consistency, inspection readiness, and continuous improvement initiatives.

• Lead the end-to-end implementation and rollout of new modules within Veeva, ensuring alignment with business needs and regulatory requirements.
• Serve as the Quality Systems lead and subject matter expert (SME) processes, driving standardization and harmonization across the organization.
• Partner with cross-functional stakeholders (Quality Assurance, Manufacturing, Supply Chain, and IT) to define system requirements, workflows, and business processes.
• Oversee system configuration, user acceptance testing (UAT), and validation activities (e.g., CSV/CSA) to ensure the system is fit for intended use and compliant with global GMP regulations.
• Assist with developing and executing implementation plans, including timelines, resource planning, risk mitigation strategies, and communication plans.
• Author and/or review governing documents (SOPs, work instructions, and training materials) to support the new modules and ensure alignment with QMS requirements.
• Lead training strategy and rollout, including role-based curricula, to ensure successful user adoption and adherence to new processes.
• Monitor system performance and user feedback post-implementation; identify and implement continuous improvements and enhancements.
• Collaborate with internal stakeholders to ensure alignment and effective utilization of newly implemented and current modules.
• Act as the primary point of contact for system-related issues, deviations, and change controls.
• Support internal and external audits and health authority inspections by providing system documentation, demonstrating functionality, and addressing inquiries.

• Bachelor’s degree in a scientific discipline.
• 12+ years’ experience in Quality and Quality Systems in the drug development industry with knowledge of cGMP/ICH/FDA/EMA regulations.
• Prior experience implementing or supporting electronic QMS platforms, ideally Veeva Vault QMS.
• Strong project management and change management skills.
• Ability to drive process standardization and continuous improvement.
• Demonstrated 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 and ability to manage multiple tasks simultaneously.
• Strong interpersonal skills including relationship building, conflict resolution, and verbal and written communication.

The salary range for this position is $197,129 to $221,404 USD.

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws. Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.