Country Quality Lead & Qualified Person - PETNET UK

Country Quality Lead & Qualified Person – PETNET UK

PETNET Solutions Inc., a Siemens Healthineers company, is seeking a Country Quality Lead & Qualified Person – UK. This position is based in Dunstable, England.

As the global leader in the supply of positron emission tomography (PET) radiopharmaceuticals, PETNET pioneered the commercial PET radiopharmacy model and continues to shape the future of molecular imaging. We are looking for an experienced quality professional to lead UK quality operations, ensure regulatory compliance, and support QP certification and batch release of radiopharmaceuticals. You will partner with operations, regulatory, and corporate teams to maintain high standards of quality, safety, and compliance across UK sites.

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

Responsibilities

• 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, 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 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.
• 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.

Qualifications and experience

• 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 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 details

• Direct reports: 4
• Geographic scope: United Kingdom (sites in Nottingham, Mt. Vernon, and Dunstable), based at Dunstable location
• Seniority level: Mid-Senior level
• Employment type: Full-time
• Job function: Quality Assurance
• Industries: Medical Equipment Manufacturing, Hospitals and Health Care, Biotechnology Research
• Travel: Up to 75% of the time

Benefits

• 26 days\’ holiday with the option to buy or sell an additional 5 days
• Up to 10% employer pension contribution
• Share and bonus scheme
• Flexible benefits including private medical insurance and dental cover
• Corporate social responsibility opportunities including 2 paid volunteering days per year and access to a 24/7 employee assistance programme

Note

Location: Windlesham, Reading, Wembley, Slough, and other UK sites may be listed as part of location options; this listing pertains to PETNET UK operations based in Dunstable, England.