Head of Sterility Assurance
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Questa posizione è in Siemens
Il processo di selezione sarà interamente gestito Siemens.
Questa opportunità è disponibile in Barcelona - Spain, Colleretto Giacosa - Italy, Lisses - France, Northwood - United Kingdom, Saint-Genis-Pouilly - France.
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Head of Sterility Assurance (f/m/d) Job ID Posted since 22-Jul-2026 Organization Siemens Healthineers Field of work Quality Management Company Advanced Accelerator Applications Molecular Imaging France SAS Experience level Experienced Professional Job type Full-time Work mode Office/Site only Employment type Permanent Location(s)
- Barcelona - Barcelona - Spain
- Colleretto Giacosa - Torino - Italy
- Lisses - Île-de-France - France
- Northwood - London City of - United Kingdom
- Saint-Genis-Pouilly - Auvergne-Rhône-Alpes - France
- Lead Sterility Assurance activities across all SHS Radiopharma sites and drive global aseptic improvement initiatives.
- Ensure compliance of all Sterility Assurance activities with applicable GMP requirements, regulatory expectations, corporate quality standards, and internal procedures.
- Chair the global Sterility Assurance Committee, including the development of global SOPs, aseptic training programs, and oversight of Environmental Monitoring (EM) performance across the network.
- Define and coordinate CAPAs related to Sterility Assurance, including those arising from health authority inspections, audits, deviations, and escalations.
- Provide leadership and support during quality or compliance crisis situations.
- Act as a subject matter expert, supporting site investigations and the definition and implementation of effective CAPAs.
- Support the definition of User Requirement Specifications (URS) and validation strategies for new facilities, equipment, and production lines.
- Define, prioritize, and coordinate global Sterility Assurance projects across the SHS Radiopharma network.
- Conduct site visits and provide guidance to ensure consistent application of cGMP requirements, quality standards, and aseptic practices.
- Collaborate closely with Quality and Technical Operations teams to drive alignment, best practice sharing, and a consistent approach across sites.
- Serve as a member of the Quality Leadership Team (QLT), contributing to the overall quality strategy and governance of the organization.
- University degree in Life Sciences (Biology, Microbiology), Pharmacy, or a related scientific discipline. Qualified Person certification is a strong advantage.
- Minimum 8 years of experience in pharmaceutical manufacturing and quality environments, with significant exposure to aseptic processes.
- Minimum 5 years of experience in Sterility Assurance within a GMP-regulated pharmaceutical.
- Strong expertise in sterility assurance principles, contamination control strategies, environmental monitoring, and aseptic processing.
- Proven experience supporting health authority inspections, audits
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