Executive Director, Development Quality Lead
Core
Provides phase-appropriate Quality Assurance leadership for development activities, embedding quality planning and risk management into development execution for a biopharmaceutical company.
Role type
Executive Director, Development Quality Lead
Builds
Development quality oversight, governance packs, readiness milestones, and inspection-ready evidence packages for novel therapeutics.
Domain
Biopharmaceuticals / Drug Development
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
QA governance, risk management, deviation/CAPA/change control application, vendor oversight, cross-functional leadership, executive communication, Veeva Vault Quality proficiency
Preferred skills
Pharmaceutical/biotech development quality experience, CRO/CMO partner oversight experience
Technologies
Veeva Vault Quality
Responsibilities
Define phase-appropriate QA oversight model and governance cadence; Embed risk management into development execution; Guide deviations/CAPA/change control expectations; Oversee development partners/vendors; Maintain inspection readiness plans and evidence packages.
Seniority
Executive Director, strategic leadership