Affiliates Manager

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 3PLsOnboard 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 ResponsabilitàQualification 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 fondamentalicomprehensive healthcare programs work‑life balance initiatives relocation support competitive salary with bonuses flexible working arrangements remote work options
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