Global Head of Sterility Assurance

Siemens Healthineers; Saint-Genis-Pouilly; Sur place; EUR 80 000 - 90 000; Plein temps

Résumé du poste

Siemens Healthineers Radiopharma seeks a Sterility Assurance Head to lead global aseptic quality initiatives, ensuring GMP compliance across sites in Europe and beyond. This senior role drives CAPA, SOP development, and environmental monitoring programs while collaborating with Quality and Technical Operations teams.

The role requires a life sciences degree, extensive GMP/aseptic experience, and strong leadership in cross-functional teams, with travel up to 30% as needed.

Qualifications

• 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.
• Fluency in English is required; additional European languages are considered an asset.

Responsabilités

• 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.

Connaissances

Leadership

GMP Compliance

Sterility Assurance

Environmental Monitoring

CAPA Management

Risk Assessment

Regulatory Inspections

Project Management

Quality Improvement

English Fluency

Formation

University degree in Life Sciences (Biology, Microbiology) or Pharmacy

Qualified Person certification (advantage)

Outils

Quality Management Systems

cGMP Knowledge

Audit Tools

Description du poste

Siemens Healthineers Radiopharma seeks a Sterility Assurance Head to lead global aseptic quality initiatives, ensuring GMP compliance across sites in Europe and beyond. This senior role drives CAPA, SOP development, and environmental monitoring programs while collaborating with Quality and Technical Operations teams.

The role requires a life sciences degree, extensive GMP/aseptic experience, and strong leadership in cross-functional teams, with travel up to 30% as needed.