Job Description
Alfasigma is a privately held global healthcare company founded over 75 years ago in Italy, where it remains headquartered today in Bologna and Milan. The Group operates in over 100 markets spanning Europe, North and South America, Asia, and Africa. Over three years ago, we embarked on a transformative journey to become a truly global innovative healthcare company with a leading focus on Gastrointestinal (GI) health. We have experienced remarkable growth, nearly doubled our revenues, expanding geographically, and integrating several key acquisitions. We have also evolved our portfolio, expanded into rare and specialty segments, and strengthened our pipeline and people's capabilities. But our journey is far from complete! In fact, this is just the beginning of a bold new chapter in Alfasigma's history. We are committed to advancing innovation and leveraging our deep expertise to provide better health and a better quality of life for patients and consumers worldwide and expand our reach across diverse markets. Are you passionate about Quality Assurance? Join a dynamic and international environment where Quality meets Supply Chain, ensuring that pharmaceutical and Consumer Healthcare products reach patients safely, compliantly, and efficiently. In this role, you will play a key part in safeguarding product integrity across warehousing, transportation, cold chain logistics, and distribution networks, collaborating with cross-functional teams and external partners in a highly regulated environment. This is an exciting opportunity for QA professionals who enjoy operational challenges, stakeholder interaction, and continuous improvement within an end-to-end supply chain ecosystem. Purpose of the Job Ensure compliance of supply chain operations with Good Distribution Practices (GDP) and applicable Italian/EU regulations, maintaining product quality, integrity, and traceability across the pharmaceutical and CHC distribution network. Principal Accountabilities Quality & Compliance Ensure full compliance with EU GDP guidelines (2013/C 343/01) and Italian AIFA requirements Support the maintenance and improvement of the Global Quality Management System (QMS) related to distribution activities Manage SOPs, deviations, CAPAs, change controls, and quality risk assessments Support preparation and management of internal/external audits and inspections (AIFA, EMA, clients) Supply Chain Quality Oversight Oversee QA aspects of warehousing, transport, and distribution activities Ensure qualification and monitoring of logistic service providers (LSPs) and distributors in Italy Manage temperature-controlled logistics, including cold chain compliance Review and approve shipment documentation, deviations, and complaints related to distribution Vendor & Third-Party Management Qualify and audit 3PL providers, wholesalers, and transport partners in the Italian market Ensure technical agreements (Quality Agreements) are in place and up-to-date Monitor KPIs and quality performance of third parties Product Quality & Traceability Support serialization and traceability requirements (e.g., EU Falsified Medicines Directive – FMD) Manage product complaints, recalls, and returns in line with GDP Ensure batch traceability across the Italian supply chain Cross-functional Collaboration Work closely with Regulatory Affairs, Supply Chain, Customer Service, and QA teams Provide GDP training to internal teams and external partners Act as QA contact for Italian affiliate and distribution network Qualifications 3–5+ years in Quality Assurance or Supply Chain QA within pharmaceutical industry Strong experience with GDP compliance, ideally in Italy Degree in Pharmacy , Life sciences Good knowledge of specific EU GDP guidelines Italian pharmaceutical distribution requirements (AIFA) Cold chain and temperature monitoring systems Experience with eQMS tools (deviations, CAPA, audits) Familiarity with serialization/FMD systems is a plus Excellent communication skills in Italian and English Ability to work cross-functionally and manage stakeholders Problem-solving and risk-based thinking Why Join Alfasigma: At Alfasigma, we foster a culture where the courage to innovate is key to our success. We offer a competitive salary, comprehensive benefits, and extensive opportunities for professional growth and development. Our commitment to people and patients is at the heart of everything we do. We value diversity and welcome individuals with unique perspectives and experiences. We believe that open-mindedness, collaboration, and a shared passion for innovation are essential to achieving meaningful progress. Join Alfasigma and become part of a forward-thinking team dedicated to shaping the future of the pharmaceutical industry.
