Head of Sterility Assurance, Italy (f/m/d)

ppAt Siemens Healthineers (SHS) Radiopharma, we are committed to driving sustainable progress through cutting-edge technology. We empower our customers by bridging the physical and digital worlds—enhancing the way we live, work, and move, today and for future generations. /p pWe believe that business success begins with our people. That’s why we prioritize a culture where individuals thrive. Our diverse team is ready to support, inspire, and challenge you to grow in new and meaningful ways. Together, there are limitless possibilities of where our shared journey may lead. /p pAs the global leader in the supply of positron emission tomography (PET) radiopharmaceuticals, SHS Radiopharma pioneered the commercial PET radiopharmacy model over 30 years ago—and continues to shape the future of molecular imaging. /p pbSterility Assurance Head /b, responsible for defining and implementing the Sterility Assurance strategy across the SHS Radiopharma International network, ensuring GMP compliance, contamination control, business continuity, process harmonization, and operational excellence across all regulated activities. /p pbLocation: /b Colleretto Giacosa (Italy), Saint-Genis-Pouilly (France), Lisses (France), Barcelona (Spain), Dunstable (United Kingdom) /p pbSalary range /b /p ul liItaly : €80,000 - €90,000 + benefits /li /ul pbYour role: /b /p ul liLead Sterility Assurance activities across all SHS Radiopharma sites and drive global aseptic improvement initiatives. /li liEnsure compliance of all Sterility Assurance activities with applicable GMP requirements, regulatory expectations, corporate quality standards, and internal procedures. /li liChair the global Sterility Assurance Committee, including the development of global SOPs, aseptic training programs, and oversight of Environmental Monitoring (EM) performance across the network. /li liDefine and coordinate CAPAs related to Sterility Assurance, including those arising from health authority inspections, audits, deviations, and escalations. /li liProvide leadership and support during quality or compliance crisis situations. /li liAct as a subject matter expert, supporting site investigations and the definition and implementation of effective CAPAs. /li liSupport the definition of User Requirement Specifications (URS) and validation strategies for new facilities, equipment, and production lines. /li liDefine, prioritize, and coordinate global Sterility Assurance projects across the SHS Radiopharma network. /li liConduct site visits and provide guidance to ensure consistent application of cGMP requirements, quality standards, and aseptic practices. /li liCollaborate closely with Quality and Technical Operations teams to drive alignment, best practice sharing, and a consistent approach across sites. /li liServe as a member of the Quality Leadership Team (QLT), contributing to the overall quality strategy and governance of the organization. /li /ul pbTravel: /b Required to perform job function (up to 30%) /p pbYour expertise: /b /p ul liUniversity degree in Life Sciences (Biology, Microbiology), Pharmacy, or a related scientific discipline. Qualified Person certification is a strong advantage. /li liMinimum 8 years of experience in pharmaceutical manufacturing and quality environments, with significant exposure to aseptic processes. /li liMinimum 5 years of experience in Sterility Assurance within a GMP-regulated pharmaceutical. /li liStrong expertise in sterility assurance principles, contamination control strategies, environmental monitoring, and aseptic processing. /li liProven experience supporting health authority inspections, audits, investigations, deviations, and CAPA management. /li liDemonstrated ability to lead global quality initiatives, drive process harmonization, and influence cross-functional and international teams. /li liExcellent problem-solving, decision-making, and organizational skills, with strong attention to detail. /li liAbility to manage priorities in a complex and fast-paced environment while maintaining a strong quality and compliance mindset. /li liHigh level of autonomy, accountability, and sense of urgency. /li liAdaptability and openness to change, with a continuous improvement mindset. /li liFluency in English is required; additional European languages are considered an asset. /li /ul pbWho we are: /b We are a team of more than 74,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways. /p pbHow we work: /b When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably. Check our Careers Site at Jobs at Siemens Healthineers AG /p pAs an equal opportunity employer, we welcome applications from individuals with disabilities. /p /p #J-18808-Ljbffr