Affiliates Manager

05 ago - Italia
Altro

Experteer Overview In this role you will drive quality excellence across Chiesi's global affiliate network as part of Global Technical Operations & Supply. You lead and harmonize local quality systems, collaborate with central teams, and guide regulatory‐compliant improvements. You'll influence global quality strategies, ensure safety and efficacy, and work with cross‐functional partners to elevate standards. The position offers global scope, impactful projects, and growth within a purpose‐driven biopharma group.
Retribuzione / Benefits Core member of the Quality Affiliates Transformation Project team and involved in related activities
Active participant in the Affiliates Quality Council
Data collection and co‐leadership of the Regional Quality Council
Support to Affiliates for Local Quality Management Systems definition, implementation, and continuous improvement
Standardization of local processes and alignment to Global Quality Standards (SOPs)
Oversee local operations with focus on local products/CMOs and 3PLs
Onboard colleagues to Global projects (e.g., Veeva implementation)




Serve as primary quality contact for affiliates on topics like change control and deviation management
Draft and discuss Quality and Technical Agreements with Affiliates
Define Quality organization/structure for new Affiliates
Prepare for and participate in regulatory inspections at Affiliates
Responsabilità Qualification in a scientific or technical discipline and >8 years of relevant industry experience
Knowledge of quality standards, regulatory guidelines, and biotech/pharma requirements
Experience conducting quality activities: audits, compliance monitoring, regulatory inspections, system implementation
Strong analytical skills to interpret quality data and regulatory requirements
Proficiency in quality documentation management with attention to detail
Requisiti fondamentali comprehensive healthcare programs
work‐life balance initiatives
relocation support
competitive salary with bonuses

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