Global Head, Sterility Assurance & Aseptic Excellence

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

Benefits offered by this job

Salary range: €80,000–€90,000 + benets

Job summary

Siemens Healthineers AG in Paris area seeks a Sterility Assurance Head to define and drive Sterility Assurance strategy across SHS Radiopharma globally. You will ensure GMP compliance, lead the Sterility Assurance Committee, and oversee environmental monitoring and CAPA management.

The role requires 8+ years in pharma manufacturing/quality with sterile processing, English fluency, and willingness to travel up to 30%.

Qualifications

• University degree in Life Sciences, Pharmacy, or related field.
• Qualified Person certification is a strong advantage.
• Minimum 8 years in pharmaceutical manufacturing/quality environments; aseptic exposure.
• Minimum 5 years in Sterility Assurance within GMP pharma.

Responsibilities

• Lead Sterility Assurance activities across SHS Radiopharma sites.
• Ensure GMP compliance and contamination control across the network.
• Chair global Sterility Assurance Committee and develop SOPs.
• Coordinate CAPAs from inspections, audits, deviations, and escalations.
• Provide leadership during quality/compliance crises.
• Support site investigations and CAPA implementation.
• Define URS and validation strategies for new facilities/equipment.
• Lead global Sterility Assurance projects and site visits.
• Collaborate with Quality and Technical Operations for alignment.
• Be a member of the Quality Leadership Team and contribute to governance.

Skills

Leadership

GMP compliance

Quality systems

Regulatory knowledge

Strategic planning

Project coordination

Problem solving

Cross-functional collaboration

Education

University degree in Life Sciences or Pharmacy

Job description

Siemens Healthineers AG in Paris area seeks a Sterility Assurance Head to define and drive Sterility Assurance strategy across SHS Radiopharma globally. You will ensure GMP compliance, lead the Sterility Assurance Committee, and oversee environmental monitoring and CAPA management.

The role requires 8+ years in pharma manufacturing/quality with sterile processing, English fluency, and willingness to travel up to 30%.