ESO Quality Americas Leader
Core
Ensures quality compliance for sterile Galderma products manufactured by Contract Manufacturing Organizations (CMOs) and internal sites, covering semi-solid and oral pharmaceutical/cosmetic products.
Role type
Senior Quality Leader (Sterile Products & CMO Oversight)
Builds
Sterile pharmaceutical and cosmetic products for global markets
Domain
Dermatology / Pharmaceutical Manufacturing / Quality Assurance
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; Support investigations, complaints, and CAPA for product quality issues; Ensure compliance with EU-GMP, FDA, and ICH guidelines; Review and approve regulatory documents (CMC, PIF, INDs, CTAs); Support inspection readiness for new product launches.
Seniority
Senior, hands-on IC with leadership responsibilities
