Your Responsibilities: :
The purpose of the role is to manage the activities linked to the quality oversight of the Cold Chain activities in the scope of clinical material for development stages from clinical phases I to III to ensure those activities are aligned with regulatory expectations and GSK standards, managing risks as appropriate.
- Develop Written Standards and Manage day-to-day activities to provide adequate quality oversight to cold chain management for vaccine clinical material including investigational medicinal products (IMPs).
- Develop and Maintain ability to assess Temperature Excursions in a timely manner
- Identify, Develop and Implement improvements to Temperature Excursions Management processes
- Support in collaboration with CSO the strategy of the Cold Chain Management for vaccine IMPs
- Collaborate with Q4R&D and other GSK divisions to support GxP inspection when Cold Chain Management is in the scope
- Collaborate and align with the relevant experts to ensure the cold chain management of IMPs is compliant with regulations and local requirements
- Identify, document and manage risks in the scope of cold chain quality
- Identify, manage and escalate issues related to cold chain quality as appropriate following GSK vaccines procedures
- Collaborate with the Third Party Oversight Quality to ensure that the requirements of the Cold Chain Management of IMPs are taken into account during the Quality Assessment of any potential Third Party and are subsequently reflected in the Quality Agreement
- Ensure adequate oversight of cold chain and set up KPIs to measure the performance of those processes
- Ensure close relationships with GQC/ARD to establish the cold chain budget at IMPs release stage
- Ensure temperature excursions are managed and the QA decision is provided in a timely manner
- Investigate any trend relating to sites/services providers in the scope of cold chain issues
- Support the investigation of deviation relating to the Cold Chain Management processes
- Support the selection and qualification of third parties and service providers used in the supply and distribution of IMPs as well as the investigation in case of issue and for cause audits as needed
- Actively Maintain Training Status to perform activities related to Cold Chain
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Global Quality Departments is responsible for setting up all global rules and regulations to ensure GSK vaccine products are manufactured, tested, released and distributed in compliance with regulatory requirements.
The QA Belgium departments manage all product quality related activities in industrial operations in Belgium, including regulatory compliance. The scope covers any action that potentially impacts final product quality. The QA Belgium department is also responsible for the release of final products made in Belgium and abroad.
Quality for Research & Development in partnership with R&D teams promotes quality and enables them ensuring activities of Research & Development are delivered in a compliant and sustainable way, in order to guarantee patient safety, company and regulators satisfaction, as well as successful product pipeline delivery.
GSK is one of the world’s leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world’s leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world’s countries.
For further information, please visit www.gsk.com.
Why You? – University degree: master degree in Sciences/Engineering e.g. Pharmacist / Master in Sciences / Bio Engineer
- 5 years in the Pharmaceutical/Biotech industry with significant experience of GMP within a major authority jurisdiction (US/EU/AU/Canada).
- A minimum of 1 to 2 years in a quality management position with optional additional experience in production and/or quality control
- Knowledge of the framework within which a pharmaceutical product has to be transported, stored and distributed and of the bridging requirements between production and use in clinical studies (GMP/GCP)
- Good Understanding of cold chain management from stability data development to validation of transport and storage conditions
- Professional writing and speaking in English
Why GSK? :
At GSK, our mission is to improve the quality of human life by enabling people to do more, feel better and live longer. Our three world-leading businesses research and deliver innovative medicines, vaccines and consumer healthcare products. We need a talented and motivated workforce to deliver against our strategy. To achieve this, we strive to attract the best people and to create an environment that empowers and inspires.
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