Executive Director, Quality Systems & Operational Excellence Lead
Core
Owns QMS process design, harmonization, and operational excellence roadmap to ensure consistent, efficient, inspection-ready execution for a biopharmaceutical company.
Role type
Executive Director, Quality Systems & Operational Excellence
Builds
QMS architecture, standards, templates, governance frameworks, and operational excellence initiatives for a virtual biotech organization.
Domain
Biopharmaceuticals / Quality Management Systems (QMS) / Operational Excellence
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QMS architecture, process harmonization, SOP governance, quality event trending, document control, training oversight, operational excellence leadership, KPI cadence facilitation, benefits tracking, cycle-time improvement, change management, IT QA controls, computerized system quality requirements, executive risk communication, inspection readiness discipline, audit narrative readiness, evidence retrieval, traceability, virtual biotech operations
Preferred skills
Pharmaceutical/biotech Quality Systems, global standards deployment, lifecycle management (Development QA to Commercial QA), virtual biotech environment operations, Veeva Vault Quality/QMS proficiency, Quality Docs workflows, deviations, CAPA, change control, training, document management
Technologies
Veeva Vault Quality, Veeva Vault Quality Docs
Responsibilities
Own QMS architecture, process ownership model, and standards/templates; Maintain SOP governance, periodic reviews, training impact requirements, and document control; Lead OPEX portfolio (simplification, RFT, cycle time reduction); Own Quality KPI framework and cadence; Ensure QMS documentation and evidence are audit/inspection-ready; Lead quality event trending and signal detection across the product lifecycle.
Seniority
Executive Director, strategic leadership & cross-functional influence
