Global Sterility Assurance Leader - Aseptic GMP

Siemens Healthineers AG; Dunstable; On-site; GBP 70,000 - 110,000; Full time

Job summary

Siemens Healthineers Radiopharma is seeking a Sterility Assurance Head to define and implement strategies across the global network, ensuring GMP compliance, contamination control, and robust CAPA management.

You will lead the Sterility Assurance Committee, develop global SOPs, oversee environmental monitoring, and drive aseptic improvements across sites in Europe and beyond. Fluent English and extensive GMP experience are essential.

Qualifications

• University degree in Life Sciences or related field; QP certification preferred.
• 8+ years in pharma manufacturing/quality with aseptic experience.
• 5+ years in Sterility Assurance within GMP environment.
• Strong knowledge of sterility, contamination control, EM, and aseptic processing.
• Experience supporting health authority inspections and CAPA.
• Ability to lead global quality initiatives and cross-functional teams.
• Fluent English; additional European languages a plus.

Responsibilities

• Lead Sterility Assurance across SHS Radiopharma sites and drive global aseptic improvements.
• Ensure GMP compliance and regulatory alignment for Sterility activities.
• Chair global Sterility Assurance Committee and develop SOPs and training.
• Define and coordinate CAPAs from inspections, audits, deviations, and escalations.
• Provide leadership during quality or compliance crises.
• Support investigations and CAPA implementation.
• Assist URS and validation strategies for new facilities and equipment.
• Define and coordinate global Sterility Assurance projects.
• Conduct site visits to ensure cGMP and aseptic practices.
• Collaborate with Quality and Technical Ops to harmonize practices.
• Serve on Quality Leadership Team contributing to strategy.

Skills

Sterility Assurance

GMP Compliance

Environmental Monitoring

CAPA Management

Quality Leadership

Project Leadership

English Fluency

Education

University degree in Life Sciences or related field

Qualified Person certification advantageous

Tools

Environmental Monitoring Systems

Regulatory Auditing Tools

Job description

Siemens Healthineers Radiopharma is seeking a Sterility Assurance Head to define and implement strategies across the global network, ensuring GMP compliance, contamination control, and robust CAPA management.

You will lead the Sterility Assurance Committee, develop global SOPs, oversee environmental monitoring, and drive aseptic improvements across sites in Europe and beyond. Fluent English and extensive GMP experience are essential.