Head of Sterility Assurance (f/m/d)

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

Job Requirements

Join us in pioneering breakthroughs in healthcare. For everyone. Everywhere. Sustainably. At Siemens Healthineers (SHS) Radiopharma, we are committed to driving sustainable progress through cutting-edge technology. We empower our customers by bridging the physical and digital worlds- enhancing the way we live, work, and move, today and for future generations.

We believe that business success begins with our people. That’s why we prioritize a culture where individuals thrive. Our diverse team is ready to support, inspire, and challenge you to grow in new and meaningful ways. Together, there are limitless possibilities of where our shared journey may lead.

As the global leader in the supply of positron emission tomography (PET) radiopharmaceuticals, SHS Radiopharma pioneered the commercial PET radiopharmacy model over 30 years ago—and continues to shape the future of molecular imaging.

We are seeking an experienced and driven professional to join our Radiopharma business as a Sterility Assurance Head, responsible for defining and implementing the Sterility Assurance strategy across the SHS Radiopharma International network, ensuring GMP compliance, contamination control, business continuity, process harmonization, and operational excellence across all regulated activities.

Location

Saint-Genis-Pouilly (France), Lisses (France), Barcelona (Spain), Dunstable (United Kingdom), or Colleretto Giacosa (Italy).

Type of contract

Permanent

Your Role

• Lead Sterility Assurance activities across all SHS Radiopharma sites and drive global aseptic improvement initiatives.


• Ensure compliance of all Sterility Assurance activities with applicable GMP requirements, regulatory expectations, corporate quality standards, and internal procedures.


• Chair the global Sterility Assurance Committee, including the development of global SOPs, aseptic training programs, and oversight of Environmental Monitoring (EM) performance across the network.


• Define and coordinate CAPAs related to Sterility Assurance, including those arising from health authority inspections, audits, deviations, and escalations.


• Provide leadership and support during quality or compliance crisis situations.


• Act as a subject matter expert, supporting site investigations and the definition and implementation of effective CAPAs.


• Support the definition of User Requirement Specifications (URS) and validation strategies for new facilities, equipment, and production lines.


• Define, prioritize, and coordinate global Sterility Assurance projects across the SHS Radiopharma network.


• Conduct site visits and provide guidance to ensure consistent application of cGMP requirements, quality standards, and aseptic practices.


• Collaborate closely with Quality and Technical Operations teams to drive alignment, best practice sharing, and a consistent approach across sites.


• Serve as a member of the Quality Leadership Team (QLT), contributing to the overall quality strategy and governance of the organization.

Travel

Required to perform job function (up to 30%)

Work Experience

Your profile:

• University degree in Life Sciences (Biology, Microbiology), Pharmacy, or a related scientific discipline. Qualified Person certification is a strong advantage.


• Minimum 8 years of experience in pharmaceutical manufacturing and quality environments, with significant exposure to aseptic processes.


• Minimum 5 years of experience in Sterility Assurance within a GMP-regulated pharmaceutical.


• Strong expertise in sterility assurance principles, contamination control strategies, environmental monitoring, and aseptic processing.


• Proven experience supporting health authority inspections, audits, investigations, deviations, and CAPA management.


• Demonstrated ability to lead global quality initiatives, drive process harmonization, and influence cross-functional and international teams.


• Excellent problem-solving, decision-making, and organizational skills, with strong attention to detail.


• Ability to manage priorities in a complex and fast-paced environment while maintaining a strong quality and compliance mindset.


• High level of autonomy, accountability, and sense of urgency.


• Adaptability and openness to change, with a continuous improvement mindset.


• Fluency in English is required; additional European languages are considered an asset.

Salary range

Italy : €80,000 - €90,000 + benefits

Who We Are

We are a team of more than 74,000 highly dedicated Healthineers in more than 70 countries. As a leader in medical technology, we constantly push the boundaries to create better outcomes and experiences for patients, no matter where they live or what health issues they are facing. Our portfolio is crucial for clinical decision-making and treatment pathways.

How We Work

When you join Siemens Healthineers, you become one in a global team of scientists, clinicians, developers, researchers, professionals, and skilled specialists, who believe in each individual’s potential to contribute with diverse ideas. We are from different backgrounds, cultures, religions, political and/or sexual orientations, and work together, to fight the world’s most threatening diseases and enable access to care, united by one purpose: to pioneer breakthroughs in healthcare. For everyone. Everywhere. Sustainably.

As an equal opportunity employer, we welcome applications from individuals with disabilities.

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