Experteer Overview

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As Sterility Assurance Head, you will guide the global sterility program across SHS Radiopharma sites to ensure GMP-compliant aseptic operations. You will lead a cross-functional quality initiative to standardize processes, investigations, and CAPAs while supporting inspections and regulatory expectations. The role sits at the heart of quality leadership, driving alignment and continuous improvement in aseptic processing.

Your work will shape how we maintain high sterile standards across multiple sites and countries, delivering reliable, compliant production for patients.

Compensaciones / Incentivos

- Lead Sterility Assurance activities across SHS Radiopharma sites and push global aseptic improvement
- Ensure GMP/compliance for all Sterility Assurance activities
- Chair the global Sterility Assurance Committee and develop global SOPs and training
- Define and coordinate CAPAs related to Sterility Assurance and inspections
- Provide leadership during quality or compliance crises
- Support site investigations and implementation of CAPAs




- Assist URS and validation strategies for new facilities/equipment/lines
- Coordinate global Sterility Assurance projects and harmonize practices
- Perform site visits to ensure consistent cGMP and aseptic practices
- Collaborate with Quality and Technical Operations to align across sites
- Participate in the Quality Leadership Team and contribute to quality strategy

Responsabilidades

- University degree in Life Sciences, Pharmacy, or related discipline
- Minimum 8 years in pharmaceutical manufacturing/quality environments with aseptic exposure
- Minimum 5 years in Sterility Assurance within GMP
- Strong expertise in xugodme sterility assurance, contamination control, EM, and aseptic processing
- Experience supporting health authority inspections, audits, deviations, and CAPA
- Proven ability to lead global quality initiatives and cross-functional teams
- Strong problem-solving, decision-making, and organizational skills
- Ability to manage priorities in a fast-paced environment with quality focus
- High autonomy, accountability, and urgency; adaptability and continuous improvement mindset
- Fluency in English; other European languages advantageous

Requisitos principales

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📌 Head of Sterility Assurance (f/m/d) (Barcelona)
🏢 Siemens
📍 Barcelona