Executive Director, Quality Systems & Operational Excellence Lead
About this role
About the Role
Executive Director, Quality Systems & Operational Excellence Lead responsible for owning QMS design, governance, and the operational excellence roadmap to drive inspection-ready execution across the product lifecycle in a virtual biotech environment.
What You'll Do
- Own QMS architecture, process ownership model, and standards/templates; drive harmonization across Development QA, IT QA, and Commercial QA interfaces across the product lifecycle.
- Maintain SOP governance, periodic reviews, training impact requirements, document control, and training compliance across a virtual biotech organization, ensuring fit-for-purpose processes and inspection-ready records.
- Produce deliverables such as QMS process maps, SOP governance calendars, standards/template libraries, lifecycle quality event trending reports, and training/document control dashboards.
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