Head of Sterility Assurance (f/m/d), Île-de-France

By bridging the gap between the physical and digital worlds, we help to accelerate digitalisation and sustainability: so that our customers around the world can become more competitive, resilient and sustainable.

Tasks

• 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.
• Travel: Required to perform job function (up to 30%)

Profil

• 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, investigations, deviations, and CAPA management.
• Demonstrated ability to lead global quality initiatives, drive process harmonization, and influence cross-functional and international teams.
• Excellent problem-solving, decision-making, and organizational skills, with strong attention to detail.
• Ability to manage priorities in a complex and fast-paced environment while maintaining a strong quality and compliance mindset.
• High level of autonomy, accountability, and sense of urgency.
• Adaptability and openness to change, with a continuous improvement mindset.
• Fluency in English is required; additional European languages are considered an asset.