Global Sterility Assurance Leader

Siemens Healthineers AG; Barcelona; Sur place; EUR 80 000 - 90 000; Plein temps

Résumé du poste

Siemens Healthineers AG is seeking an experienced Sterility Assurance Head to lead global aseptic initiatives across SHS Radiopharma sites. You will drive GMP-compliant strategies, CAPA management, and regulatory readiness while partnering with Quality and Technical Operations to harmonize practices.

The role requires extensive pharma manufacturing experience, strong leadership, and fluency in English, with travel up to 30% as needed across Europe.

Qualifications

• University degree in Life Sciences or related field required.
• Qualified Person certification is a strong advantage.
• Minimum 8 years in pharma manufacturing and quality environments with exposure to aseptic processes.
• Minimum 5 years in Sterility Assurance within GMP-regulated pharma.
• Strong expertise in sterility assurance, contamination control, environmental monitoring, and aseptic processing.
• Experience supporting health authority inspections, audits, investigations, deviations, and CAPA management.
• Proven ability to lead global quality initiatives and harmonize processes across sites.
• Excellent problem-solving, decision-making, and organizational skills.
• High autonomy, accountability, and urgency; fluent English; other European languages a plus.

Responsabilités

• Lead Sterility Assurance activities across all SHS Radiopharma sites and drive global aseptic improvement initiatives.
• Ensure compliance of Sterility Assurance activities with GMP, regulatory expectations, quality standards, and procedures.
• Chair the global Sterility Assurance Committee and develop global SOPs, aseptic training, and EM oversight.
• Define and coordinate CAPAs related to Sterility Assurance from inspections, audits, deviations, and escalations.
• Provide leadership during quality or compliance crisis situations.
• Support site investigations and implementation of effective CAPAs.
• Support URS definition and validation strategies for new facilities, equipment, and lines.
• Define, prioritize, and coordinate global Sterility Assurance projects across the network.
• Conduct site visits and ensure consistent application of cGMP and aseptic practices.
• Collaborate with Quality and Technical Operations to share best practices and align across sites.
• Serve on the Quality Leadership Team and contribute to governance.

Connaissances

Sterility Assurance

GMP compliance

Aseptic processing

CAPA management

Quality leadership

Regulatory inspections

Environmental Monitoring

Cross-functional leadership

Problem solving

English fluency

Formation

University degree in Life Sciences

Qualified Person certification (advantage)

Description du poste

Siemens Healthineers AG is seeking an experienced Sterility Assurance Head to lead global aseptic initiatives across SHS Radiopharma sites. You will drive GMP-compliant strategies, CAPA management, and regulatory readiness while partnering with Quality and Technical Operations to harmonize practices.

The role requires extensive pharma manufacturing experience, strong leadership, and fluency in English, with travel up to 30% as needed across Europe.