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. /ppWe 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. /ppAs the general 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. /ppWe are seeking an experienced and driven professional to join our Radiopharma business as a bSterility 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. /ph3Location /h3pSaint-Genis-Pouilly (France), Lisses (France), Barcelona (Spain), Dunstable (United Kingdom), or Colleretto Giacosa (Italy). /ph3Your role /h3ulliLead Sterility Assurance activities across all SHS Radiopharma sites and drive global aseptic improvement initiatives. /liliEnsure compliance of all Sterility Assurance activities with applicable GMP requirements, regulatory expectations, corporate quality standards, and internal procedures. /liliChair the global Sterility Assurance Committee, including the development of global SOPs, aseptic training programs, and oversight of Environmental Monitoring (EM) performance across the network. /liliDefine and coordinate CAPAs related to Sterility Assurance, including those arising from health authority inspections, audits, deviations, and escalations. /liliProvide leadership and support during quality or compliance crisis situations. /liliAct as a subject matter expert, supporting site investigations and the definition and implementation of effective CAPAs.



/liliSupport the definition of User Requirement Specifications (URS) and validation strategies for new facilities, equipment, and production lines. /liliDefine, prioritize, and coordinate global Sterility Assurance projects across the SHS Radiopharma network. /liliConduct site visits and provide guidance to ensure consistent application of cGMP requirements, quality standards, and aseptic practices. /liliCollaborate closely with Quality and Technical Operations teams to drive alignment, best practice sharing, and a consistent approach across sites. /liliServe as a member of the Quality Leadership Team (QLT), contributing to the overall quality strategy and governance of the organization. /li /ulh3Travel /h3pRequired to perform job function (up to 30%) /ph3Your expertise /h3ulliUniversity degree in Life Sciences (Biology, Microbiology), Pharmacy, or a related scientific discipline. Qualified Person certification is a strong advantage. /liliMinimum 8 years of experience in pharmaceutical manufacturing and quality environments, with significant exposure to aseptic processes. /liliMinimum 5 years of experience in Sterility Assurance within a GMP-regulated pharmaceutical. /liliStrong expertise in sterility assurance principles, contamination control strategies, environmental monitoring, and aseptic processing. /liliProven experience supporting health authority inspections, audits, investigations, deviations, and CAPA management. /liliDemonstrated ability to lead global quality initiatives, drive process harmonization, and influence cross-functional and international teams. /liliExcellent problem-solving, decision-making, and organizational skills, with strong attention to detail. /liliAbility to manage priorities in a complex and fast-paced environment while maintaining a strong quality and compliance mindset.



/liliHigh level of autonomy, accountability, and sense of urgency. /liliAdaptability and openness to change, with a continuous improvement mindset. /liliFluency in English is required; additional European languages are considered an asset. /li /ulh3Who we are /h3pWe 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. /ph3How we work /h3pWhen 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 /ppAs an equal opportunity employer, we welcome applications from individuals with disabilities. /ppWe care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email. Please create a profile within our talent community and subscribe to personalized job alert that will keep you posted about new opportunities. /ph3To all recruitment agencies /h3pSiemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated. /p /p #J-18808-Ljbffr

📌 Head of Sterility Assurance (f/m/d) (Barcelona)
🏢 Siemens Healthineers
📍 Barcelona