Country Quality Lead & Qualified Person - PETNET UK

At PETNET Solutions Inc., a Siemens Healthineers company, 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 global and diverse team is ready to support, inspire, and challenge you to grow in new and meaningful ways. Together, who knows where our shared journey might lead?

We are looking for a Country Quality Lead & Qualified Person – UK. This position will be based in Dunstable, England.

As the global leader in the supply of positron emission tomography (PET) radiopharmaceuticals, PETNET 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 quality professional to take on this critical leadership role. As Country Quality Lead and Qualified Person (QP), you will be responsible for ensuring PETNET’s compliance with UK and EU GMP regulations, overseeing site-level quality assurance and control activities, and providing QP certification and batch release of radiopharmaceuticals. You will partner closely with operations, regulatory, and corporate teams to maintain the highest standards of quality, safety, and compliance across our UK operations.

With a global network of 59 cyclotron-equipped radiopharmacies, PETNET offers the opportunity to reimagine your career with an industry innovator dedicated to delivering precision diagnostics and improving patient outcomes worldwide.

Join us and help shape the future of precision diagnostics while advancing patient care across the region.

You will make an impact by:

·Ensuring all operational activities across PETNET UK sites fully comply with current Good Manufacturing Practices (cGMP), applicable legal and regulatory requirements, and the corporate quality management system.

·Establishing and maintaining a robust quality organization within the UK to support compliance and operational excellence.

·Overseeing the implementation, monitoring, and completion of all quality programs and documentation, including quality reporting, incident management, and escalation processes, to ensure timely and GMP-compliant decision-making.

·Leading inspection readiness efforts and ensuring successful outcomes of Health Authority inspections across all UK sites through proactive preparation and continuous quality improvement.

Your responsibilities in this role are to:

·Provide strategic and technical leadership for quality operations across all UK PETNET sites.

·Ensure the UK Country Quality System is compliant with current GMP regulations and aligned with corporate quality guidelines.

·Conduct annual audits of UK manufacturing sites to verify adherence to national and corporate quality standards.

·Monitor and evaluate site quality performance using defined Key Quality Indicators (KQIs), driving continuous improvement at the national level.

·Support the drafting and revision of Quality Agreements with Contract Givers/Acceptors in collaboration with the Corporate Quality Department.

·Actively participate in inspections by regulatory authorities (e.g., MHRA) and external auditors (e.g., clients, certification bodies), including follow-up and remediation activities.

·Oversee supplier qualification activities at the national level, including audits and ongoing compliance monitoring.

·Conduct supplier audits as requested by the Corporate Quality team for centrally managed vendors.

·Lead customer complaint investigations in close coordination with the Corporate Quality Department.

·Ensure timely implementation at the national level of variations to Marketing Authorizations, in collaboration with Regulatory Affairs.

·Escalate significant Quality/cGMP issues to the International Quality Head and relevant stakeholders as appropriate.

·Conduct Quality Assessments across national sites, ensuring timely, cGMP-compliant decision-making, documentation, and follow-up, including Health Authority notifications (e.g., Rapid Alerts, recalls).

·Review QA performance reports, drive corrective and preventive actions, and ensure effective follow-up on outcomes.

·Actively participate in QA management meetings and report progress on country-level quality initiatives.

·Contribute to recruitment, selection, training, and performance development of Quality personnel across UK sites.

·Ensure quality oversight and support during the launch of new products or services.

Your success in this role is measured by:

·Minimizing the number and severity of cGMP issues identified during internal, customer, and regulatory audits or inspections.

·Timely and compliant completion of follow-up actions resulting from Health Authority inspections, including execution of required quality programs and GMP upgrades.

·Achievement of corporate Key Quality Indicators (KQIs) and Key Performance Indicators (KPIs) relevant to site and country performance.

·Demonstrated leadership and effective guidance in quality matters to local QA operations across UK sites.

·Development and implementation of a robust succession plan for the UK country quality organization.

You’ll win us over by having the following qualifications:

Education

·Scientific degree required

·Must hold the legal qualification and certification as a Qualified Person (QP) in the United Kingdom or Europe

Experience:

·Minimum of 5 years’ experience in a managerial role within a pharmaceutical Quality Department

·Demonstrated leadership capabilities with the ability to guide and develop quality teams

·Strong organizational skills, including time management, risk management, and prioritization

·In-depth knowledge of GMP and ISO quality systems and standards

·Solid understanding of national and international regulatory requirements relevant to radiopharmaceutical manufacturing

·Excellent communication skills to collaborate effectively across departments and with external partners

Job Dimensions:

·Direct Reports: 4

·Geographic Scope: United Kingdom [sites in Nottingham, Mt. Vernon, and Dunstable], based at Dunstable location

·Impact on Organization: High – this role plays a critical part in the success of PETNET UK’s Quality Assurance and Technical Operations objectives by ensuring robust cGMP compliance, enabling successful health authority inspections, and guiding timely, risk-based, and compliant decisions on quality issues (e.g., market actions). A lack of leadership or incorrect decision-making in this role could result in significant financial loss (e.g., batch rejections), reputational damage, and regulatory consequences such as GMP violations, launch delays, supply interruptions, or in severe cases, warning letters.

·Reporting Lines: International Quality Head (direct), Country Business Head – UK (functional)

Travel:Required to perform job function (up to 75%)

Benefits:

·26 days\’ holiday with the option to buy or sell an additional 5

·Up to 10% employer pension contribution

·Share and bonus scheme

·Access to our flexible benefits from private medical insurance to dental cover

·Corporate Social Responsibility opportunities including 2 paid volunteering days per year and support from our 24/7 employee assistance programme.