Senior Director, Global Quality Operations - Switzerland
Core
Leads global quality operations for clinical and commercial products, overseeing CMOs and external partners to ensure supply and regulatory compliance for transformative therapies.
Role type
Senior Director, Global Quality Operations
Builds
Global quality functions and regional structures for intermediates, drug substance, drug product, and finished goods.
Domain
Pharmaceutical/Biotech (Complement Science)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP/GDP compliance, Quality Management System (QMS) leadership, CMO/CSP oversight, batch certification and release, deviation and non-conformance management, root cause analysis, CAPA implementation, regulatory framework expertise (US/EU/Swiss), strategic planning, team development, cross-functional collaboration
Preferred skills
Experience in multiple therapeutic areas, ability to navigate global matrix organizations, continuous improvement mindset
Technologies
GxP systems, QMS platforms, regulatory databases
Responsibilities
Provide strategic and operational oversight for timely market release and safe trading of medicinal products; Define and execute global quality strategies; Lead the international Quality organization and build affiliate structures; Ensure implementation and maintenance of the Quality Management System; Oversee qualification and auditing of CMOs and CSPs; Lead batch certification and release activities; Represent Quality in inspections and audits; Collaborate cross-functionally with Regulatory and Supply Chain.
Seniority
Senior Director, strategic & operational leadership
