Associate Director, Quality System, QMS
Mirum Pharmaceuticals, Inc.
July 01, 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 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 global regulations knowledge to support compliant and efficient operations, contributing to QMS strategic direction and performance (consistency, inspection readiness, continuous improvement).
Job Functions/Responsibilities
- Lead end-to-end implementation and rollout of new Veeva modules aligned with business needs and regulatory requirements.
- Serve as Quality Systems lead/SME, driving standardization and harmonization.
- Partner with Quality Assurance, Manufacturing, Supply Chain, and IT to define system requirements, workflows, and processes.
- Oversee system configuration, UAT, and validation (e.g., CSV/CSA) for fit-for-intended-use and compliance with global GMP.
- Assist with implementation plans (timelines, resources, risk mitigation, communications).
- Author/review governing documents (SOPs, work instructions, training materials) for QMS alignment.
- Lead training strategy and rollout (role-based curricula) for adoption and adherence.
- Monitor post-implementation performance/user feedback; drive continuous improvements.
- Act as primary point of contact for system issues, deviations, and change controls.
- Support internal/external audits and health authority inspections (documentation, demonstrations, inquiries).
Qualifications
- Bachelor’s degree in scientific discipline.
Required/Preferred Skills
- 12+ years’ quality/quality systems experience in drug development; knowledge of cGMP/ICH/FDA/EMA.
- Experience implementing/supporting electronic QMS platforms (ideally Veeva Vault QMS).
- Strong project/change management skills (plus).
- Ability to drive standardization and continuous improvement; quality mindset.
- Experience writing/reviewing SOPs and quality documents.
- Expert knowledge of phase-appropriate cGxPs; leadership of QMS implementation/CI.
- Ability to interface with regulatory health authorities; knowledge of audit/vendor management.
- Excellent organization; strong interpersonal, conflict resolution, and verbal/written communication.
Compensation
- Salary range: $190,000 to $205,000 USD.
- Leads roll out and oversight of Veeva QMS modules to ensure compliance with applicable regulatory requirements.
- Manages 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 global regulations knowledge to support compliant and efficient operations, contributing to QMS strategic direction and performance (consistency, inspection readiness, continuous improvement).
Job Functions/Responsibilities
- Lead end-to-end implementation and rollout of new Veeva modules aligned with business needs and regulatory requirements.
- Serve as Quality Systems lead/SME, driving standardization and harmonization.
- Partner with Quality Assurance, Manufacturing, Supply Chain, and IT to define system requirements, workflows, and processes.
- Oversee system configuration, UAT, and validation (e.g., CSV/CSA) for fit-for-intended-use and compliance with global GMP.
- Assist with implementation plans (timelines, resources, risk mitigation, communications).
- Author/review governing documents (SOPs, work instructions, training materials) for QMS alignment.
- Lead training strategy and rollout (role-based curricula) for adoption and adherence.
- Monitor post-implementation performance/user feedback; drive continuous improvements.
- Act as primary point of contact for system issues, deviations, and change controls.
- Support internal/external audits and health authority inspections (documentation, demonstrations, inquiries).
Qualifications
- Bachelor’s degree in scientific discipline.
Required/Preferred Skills
- 12+ years’ quality/quality systems experience in drug development; knowledge of cGMP/ICH/FDA/EMA.
- Experience implementing/supporting electronic QMS platforms (ideally Veeva Vault QMS).
- Strong project/change management skills (plus).
- Ability to drive standardization and continuous improvement; quality mindset.
- Experience writing/reviewing SOPs and quality documents.
- Expert knowledge of phase-appropriate cGxPs; leadership of QMS implementation/CI.
- Ability to interface with regulatory health authorities; knowledge of audit/vendor management.
- Excellent organization; strong interpersonal, conflict resolution, and verbal/written communication.
Compensation
- Salary range: $190,000 to $205,000 USD.