Senior Manager, Quality Systems
SimulStat
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Hybrid (Redwood City, CA) or Remote, 12-month Contract (renewable)
Senior Manager, Quality Systems
Key Responsibilities
- Lead training, coaching, and guidance on Quality Events, QMS processes, and regulatory expectations
- Serve as SME and backup reviewer/approver for deviations and other Quality Events
- Support complaint and excursion investigations, plus CAPA development, implementation, and effectiveness checks
- Drive audit and inspection readiness through complete, accurate, timely documentation
- Support QMS process improvement, metrics, and trending
- Partner cross-functionally to resolve quality issues and strengthen QMS execution
Qualifications
- Bachelor’s degree in a scientific or technical field; equivalent experience considered
- 10+ years of pharma/biotech Quality Assurance or Quality Systems experience
- Strong background with deviations, investigations, CAPAs, and quality events
- Solid knowledge of GMP, Quality Risk Management, and data integrity
- Experience with eQMS platforms, audits/inspections, and quality metrics
- Strong communication and cross-functional collaboration skills
- Advanced degree or relevant Quality certification a plus
- Commercial-stage pharma/biotech experience a plus
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