Global Sterility Assurance Leader

Siemens Healthineers AG; Piemonte; On-site; EUR 80,000 - 90,000; Full time

Job summary

Siemens Healthineers AG, Radiopharma division, seeks an experienced Sterility Assurance Head to define and lead the global sterility strategy across the international network. You will ensure GMP compliance, contamination control, and operational excellence in all regulated activities.

Responsibilities include chairing the global Sterility Assurance Committee, developing SOPs, coordinating CAPAs, and guiding training and validation for new facilities and lines, while collaborating with Quality

Qualifications

• University degree in Life Sciences (Biology/Microbiology) or Pharmacy.
• 8+ years in pharmaceutical manufacturing and quality.
• 5+ years in Sterility Assurance within GMP.
• Expertise in sterility, contamination control, EM, aseptic processing.
• Experience supporting health authority inspections and CAPA.
• Proven ability to lead global quality initiatives and cross‑functional teams.
• English fluency required; other European languages a plus.

Responsibilities

• Lead Sterility Assurance activities across SHS Radiopharma sites.
• Ensure GMP compliance and regulatory expectations.
• Chair the global Sterility Assurance Committee and develop SOPs.
• Coordinate CAPAs related to Sterility Assurance.
• Provide leadership in quality or compliance crises.
• Support site investigations and validation strategies for new facilities.
• Define URS and validation strategies for equipment and lines.
• Collaborate with Quality and Technical Operations to align practices.
• Participate in Quality Leadership Team to drive governance.

Skills

Sterility assurance

GMP compliance

Environmental monitoring

CAPA management

Quality leadership

Problem solving

Education

University degree in Life Sciences or Pharmacy

Qualified Person certification

Job description

Siemens Healthineers AG, Radiopharma division, seeks an experienced Sterility Assurance Head to define and lead the global sterility strategy across the international network. You will ensure GMP compliance, contamination control, and operational excellence in all regulated activities.

Responsibilities include chairing the global Sterility Assurance Committee, developing SOPs, coordinating CAPAs, and guiding training and validation for new facilities and lines, while collaborating with Quality