Associate Director, Quality System, QMS
$190,000–$205,000 year
Hybrid · Foster City, California, United States
Job Summary
Lead the end-to-end rollout and oversight of Veeva QMS modules, ensuring compliance with global regulatory requirements; develop, implement, and maintain quality policies and procedures to support the QMS; collaborate cross-functionally with Quality Assurance, Manufacturing, Supply Chain, and IT to define system requirements, workflows, and business processes; manage system configuration, UAT, and validation activities (CSV/CSA) for GMP compliance; develop implementation plans with timelines, resources, and risk mitigation; author/review SOPs and training materials; lead training strategy and user adoption; monitor system performance and drive continuous improvement; support internal/external audits and health authority inspections with system documentation; strong knowledge of phase-appropriate cGxPs and experience leading QMS implementation and continuous improvement.
Required Qualifications
- Bachelor’s degree in scientific discipline
- 12+ years’ experience in Quality and Quality Systems in drug development
- Experience implementing or supporting electronic QMS platforms (ideally Veeva Vault QMS)
- Strong project management and change management skills
- Experience interacting with regulatory authorities at inspections
- Excellent written and verbal communication skills
- SOP development and review experience
- Knowledge of cGMP/ICH/FDA/EMA regulations
- Ability to drive process standardization and continuous improvement
- Experience with audits and health authority inspections
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