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Qualified Person (QP) - EU Importation Manager, Irvine
Client: 1054 GlaxoSmithKline Services Unlimited
Location: Irvine, United Kingdom
Job Category: Other
EU work permit required: Yes
Job Reference: e0b88d04ab2e
Job Views: 2
Posted: 08.05.2025
Expiry Date: 22.06.2025
Job Description:
We’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright, light spaces to help us thrive.
We are seeking a Qualified Person (QP) to join our QP Importation team in Market Supply and Distribution.
The role reports into a Quality Director and provides UK batch certification and release service to GSK’s Principal Trading Companies (PTCs) and Trading Partners. You will ensure compliance with the GMP aspects of the laws governing the importation of products into the EU / UK in relation to all batch-releases. As a member of the OQ 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 provide direct support for critical deviations (including attending incident management meetings). The role will involve regular interaction with cross functional colleagues so stake-holder management, whilst acting with the highest level of integrity, respect and transparency is critical.
Key Responsibilities:
1. Managing operations to allow EU/UK certification of batches of pharmaceutical products imported by the Principal Trading Company (PTC). This includes supporting management of any incidents to ensure supply sites have the information required to manage investigations and resolve incidents.
2. Ensure QP Importation operation is inspection ready and participate in regulatory inspections of the QP certification process on behalf of the PTC.
3. Perform audits of the importation supply chain (compliant to GMP, GDP and MIA authorization).
4. QP certify all batches of pharmaceutical products imported into UK in accordance with all applicable laws and guidelines (e.g., EU Guidance on GMP Part 1, Annex 16).
5. Act as key point of contact with non-EU / UK based GSK manufacturing sites (and with GSK external supply quality and GMP audit teams) for products manufactured outside the EU / UK to ensure QP certification requirements are maintained.
6. Act as a key point of contact with R&D for new products being imported into EU / UK ensuring a testing location is identified and resourced (as required) and QP certification and release activities meet programme timelines.
Location - Please note: The role can be based at any GSK site in the UK (e.g., GSK’s Head-office in London, Barnard Castle, Ware, Worthing, Irvine, Montrose, etc.), but there is a requirement to travel to Barnard Castle (County Durham) to review and approve batch-release as needed. This is expected to be circa 3 to 4 times a quarter.
About You:
You will be a qualified QP with 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 that may initially appear ambiguous or unclear and demonstrate an ability and willingness to help resolve complex problems. Resilience, calmness under pressure, strong people skills, and a continuous improvement mindset are essential.
Closing date for applications: Friday 5th of July 2024 (COB)
Basic Qualifications:
* Qualified Person (QP) qualification.
* Relevant experience (e.g., knowledge/experience of batch-release and Brexit-related processes and guidelines).
Benefits:
GSK offers a range of benefits, including:
* Competitive base salary
* Annual bonus based on company performance
* Opportunities for on-the-job training and industry conferences
* Support for professional development/chartership
* Healthcare and wellbeing programmes
* Employee recognition programmes
* Hybrid working (onsite/remote) within GSK policies (post-training)
For more about our company benefits and life at GSK, visit our webpage.
Why GSK?
GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease. We focus on vaccines, medicines, and the science of the immune system, investing in infectious diseases, HIV, respiratory/immunology, and oncology.
Our success depends on our people. We aim to create an inclusive environment where everyone can thrive, feel valued, and grow. Join us at this exciting moment in our journey to get Ahead Together.
As an Equal Opportunity Employer, we consider all qualified applicants without regard to protected classes. We support flexible working arrangements where possible.
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