Qualified Person (QP) in Worthing

We are seeking a Qualified Person (QP) to join our QP Importation team. The role reports into the Quality Trading Partner QP Importation Director, and provides UK batch certification and release service to GSK’s Trading Partners. You will ensure compliance with the GMP aspects of the laws governing the importation of products into the UK in relation to all batch releases.

As a member of the QP Importation Team you will be able to work with a degree of autonomy making critical Quality decisions whilst mentoring and supporting colleagues. In addition to undertaking regular batch release activities, you will provide direct support for critical deviations (including attending incident management meetings). The role will involve regular interaction with cross functional colleagues so stakeholder management, whilst acting with the highest level of integrity, respect and transparency is critical.

• Ensure a compliant operation is in place to allow for QP certification pharmaceutical finished products batches imported into EU/UK.
• Identify, manage, resolve or escalate product issues or incidents that impact QP certification as required.
• Collaborate directly with the named Responsible Persons, MMW QPs, Global Logistics and Supply Chain Distribution to achieve resolution.
• Ensure QP Importation is inspection ready and front regulatory inspections of QP certification and other processes.
• Ensure oversight of the supply site operations via quality meetings with the site or GSK External Quality, involvement with site audits and visits to view operations as required.
• Support regulatory inspections of supply sites, as required.
• Be a lead point of contact with the GSK manufacturing sites, GSK External Quality and GMP Audit team for products manufactured outside the EU/ UK to ensure that the requirements for QP certification are in place and maintained.
• Actively represent QP Importation at Quality Councils and on assigned projects as required.
• Advise the wider GSK/ViiV organisation on the QP certification and regulatory requirements to ensure compliance.
• QP certify batches of medicinal products imported to the UK within the QP Importation portfolio.
• Maintain knowledge of legislation changes and proposals applicable to QP Certification, evaluate impact and propose mitigation for their compliant management and/or introduction.
• Provide oversight of the existing test arrangement to ensure EU/UK product testing requirements are met for all products imported into the EU/UK.
• Own and manage Quality Systems within QP Importation and the wider Trading Partner Quality Organisation.

Location - The role can be based at any GSK site in the UK (e.g. GSK’s Headquarters in London, Barnard Castle, Ware, Worthing, etc) but there is a requirement to periodically travel to Barnard Castle (County Durham) as needed. It is anticipated that this will be circa 3 times a year.

You will be a qualified QP (Qualified Person) who has sound knowledge of global, regional and national regulatory requirements and GMP guidelines (including risk management). Knowledge/experience relating to Brexit would be advantageous. You should be comfortable dealing with issues which may initially appear ambiguous or unclear and demonstrate an ability and willingness to help resolve complex problems as they arise. You will be resilient and calm under pressure with strong people skills. You will also have a strong continuous improvement mindset.

• Qualified Person (QP) qualification.
• Relevant experience (e.g. knowledge/experience of batch-release and Brexit-related process and guidelines).

We welcome people who bring curiosity, humility and a practical approach. We are committed to inclusion and to creating a supportive environment where everyone can grow. If you enjoy solving real problems, delivering measurable results, and helping teams succeed, we encourage you to apply.