ESO Quality Americas Leader
Core
Ensures quality compliance for sterile Galderma products manufactured by Contract Manufacturing Organizations (CMOs) and external partners.
Role type
Senior Quality Leader (Sterile Products & CMO Oversight)
Builds
Sterile pharmaceutical and cosmetic products (semi-solid and oral) for global markets
Domain
Dermatology, Pharmaceutical Manufacturing, Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP, GDP, ISO, ICH regulatory knowledge, CMO/external supplier management, quality agreement negotiation, CAPA management, audit/inspection readiness, technical transfer oversight
Preferred skills
Six Sigma, Lean Manufacturing, global lifecycle management, remote team leadership
Technologies
None explicitly listed
Responsibilities
Lead approval and renewal of Technical Quality Agreements with external suppliers; Coordinate Quality Management reviews and define KPIs for CMOs; Resolve critical quality issues and discrepancies from audits or complaints; Review and approve regulatory documents (CMC sections, PIFs, INDs, CTAs); Ensure compliance with EU-GMP and ICH guidelines for medicinal and cosmetic products
Seniority
Senior, hands-on IC with global oversight