Associate Director, Quality System, QMS
Mirum Pharmaceuticals, Inc.
August 13, 2026
Remote friendly (Foster City, CA)
United States
Operations
Position Summary
Leads roll out and oversight of Veeva QMS modules to ensure compliance with applicable regulatory requirements. Manages development, implementation, and continuous improvement of QMS policies and procedures aligned with global regulatory and company guidelines.
Responsibilities
- Lead end-to-end implementation and rollout of new Veeva modules aligned to business needs and regulatory requirements.
- Serve as Quality Systems lead/SME; drive standardization and harmonization across the organization.
- Partner with Quality Assurance, Manufacturing, Supply Chain, and IT to define system requirements, workflows, and business processes.
- Oversee system configuration, UAT, and validation activities (e.g., CSV/CSA) to ensure fit for intended use and compliance with global GMP.
- Assist with implementation plans (timelines, resources, risk mitigation, and communications).
- Author and/or review SOPs, work instructions, and training materials aligned with QMS requirements.
- Lead training strategy and rollout (role-based curricula) for user adoption.
- Monitor system performance/user feedback; implement continuous improvements.
- Act as primary point of contact for system issues, deviations, and change controls.
- Support audits and health authority inspections with documentation and inquiries.
Qualifications
- Bachelor’s degree in a scientific discipline.
Required/Preferred Skills & Experience
- 12+ years’ experience in Quality/Quality Systems in drug development; knowledge of cGMP/ICH/FDA/EMA.
- Experience implementing/supporting electronic QMS platforms (ideally Veeva Vault QMS).
- Strong project and change management skills (plus).
- Process standardization/continuous improvement mindset.
- Successful SOP and Quality document writing/review.
- Phase-appropriate cGxPs expertise; experience leading Quality System implementation/continuous improvement.
- Experience interacting with regulatory health authorities; understanding of audit/vendor management.
- Excellent organizational skills and strong verbal/written communication.
Leads roll out and oversight of Veeva QMS modules to ensure compliance with applicable regulatory requirements. Manages development, implementation, and continuous improvement of QMS policies and procedures aligned with global regulatory and company guidelines.
Responsibilities
- Lead end-to-end implementation and rollout of new Veeva modules aligned to business needs and regulatory requirements.
- Serve as Quality Systems lead/SME; drive standardization and harmonization across the organization.
- Partner with Quality Assurance, Manufacturing, Supply Chain, and IT to define system requirements, workflows, and business processes.
- Oversee system configuration, UAT, and validation activities (e.g., CSV/CSA) to ensure fit for intended use and compliance with global GMP.
- Assist with implementation plans (timelines, resources, risk mitigation, and communications).
- Author and/or review SOPs, work instructions, and training materials aligned with QMS requirements.
- Lead training strategy and rollout (role-based curricula) for user adoption.
- Monitor system performance/user feedback; implement continuous improvements.
- Act as primary point of contact for system issues, deviations, and change controls.
- Support audits and health authority inspections with documentation and inquiries.
Qualifications
- Bachelor’s degree in a scientific discipline.
Required/Preferred Skills & Experience
- 12+ years’ experience in Quality/Quality Systems in drug development; knowledge of cGMP/ICH/FDA/EMA.
- Experience implementing/supporting electronic QMS platforms (ideally Veeva Vault QMS).
- Strong project and change management skills (plus).
- Process standardization/continuous improvement mindset.
- Successful SOP and Quality document writing/review.
- Phase-appropriate cGxPs expertise; experience leading Quality System implementation/continuous improvement.
- Experience interacting with regulatory health authorities; understanding of audit/vendor management.
- Excellent organizational skills and strong verbal/written communication.