Global Head of Sterility Assurance & GMP Compliance

Siemens Healthineers AG; Saint-Genis-Pouilly; On-site; EUR 80,000 - 90,000; Full time

Job summary

Siemens Healthineers Radiopharma is seeking a highly experienced Sterility Assurance Head to define and implement a global strategy across the SHS Radiopharma network. You will ensure GMP compliance, contamination control, and harmonized processes in a challenging, international setting.

The role requires 8+ years in pharma quality, 5+ years in Sterility Assurance, and fluent English. Travel up to 30% across multiple sites in Europe and beyond is expected.

Qualifications

• University degree in Life Sciences (Biology, Microbiology) or Pharmacy.
• Qualified Person certification is a strong advantage.
• Minimum 8 years in pharmaceutical manufacturing and quality environments.
• Minimum 5 years in Sterility Assurance within GMP.
• Experience supporting health authority inspections and CAPA management.
• Fluent in English; other European languages are a plus.

Responsibilities

• Lead Sterility Assurance activities across SHS Radiopharma sites and drive global aseptic improvement initiatives.
• Ensure GMP compliance, regulatory expectations, corporate quality standards, and internal procedures.
• Chair global Sterility Assurance Committee, develop global SOPs and aseptic training.
• Define and coordinate CAPAs related to Sterility Assurance and inspections.
• Provide leadership during quality or compliance crisis situations.
• Support site investigations and definition/implementation of CAPAs.
• Support URS and validation strategies for new facilities, equipment, lines.
• Coordinate global Sterility Assurance projects across the network.
• Conduct site visits to ensure consistent application of cGMP and aseptic practices.
• Collaborate with Quality and Technical Operations for alignment and best practices.
• Serve as a member of the Quality Leadership Team contributing to quality strategy.

Skills

English proficiency

Problem solving

Organizational skills

Autonomy

Education

University degree in Life Sciences/Pharmacy

Qualified Person certification (advantage)

Tools

GMP knowledge

Job description

Siemens Healthineers Radiopharma is seeking a highly experienced Sterility Assurance Head to define and implement a global strategy across the SHS Radiopharma network. You will ensure GMP compliance, contamination control, and harmonized processes in a challenging, international setting.

The role requires 8+ years in pharma quality, 5+ years in Sterility Assurance, and fluent English. Travel up to 30% across multiple sites in Europe and beyond is expected.