Head of Sterility Assurance (f/m/d)

Siemens Healthineers AG; Dunstable; Presencial; GBP 70 000 - 110 000; Tempo integral

Resumo da oferta

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.

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Sterility Assurance

GMP Compliance

Environmental Monitoring

CAPA Management

Quality Leadership

Project Leadership

English Fluency

Formação académica

University degree in Life Sciences or related field

Qualified Person certification advantageous

Ferramentas

Environmental Monitoring Systems

Regulatory Auditing Tools

Descrição da oferta de emprego

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.

We care about your data privacy and take compliance with GDPR as well as other data protection legislation seriously. For this reason, we ask you not to send us your CV or resume by email.

To All Recruitment Agencies

Siemens Healthineers' recruitment is internally managed, with external support permitted only when a qualified supplier has established a formal contract with us. Unsolicited candidate submissions and referrals, absent a current supplier contract, do not establish consent and are ineligible for fees. We delete and destroy unsolicited information, thus, would recommend you refrain from any such practices. Your adherence to our policies is appreciated.