Role Overview & Mandate
Executive Summary
Site Name: UK - County Durham - Barnard Castle, France - Evreux, Korea - Seoul, UK - Hertfordshire - Ware, USA - Maryland - Rockville,...
Reviewed by Compensation & Visa Analysts •
Sources: USCIS E-Verify & Home Office CoS
Posted Date: May 26 2023
CLOSING DATE: 15th June 2023
This role can be based at various GSK sites across the UK, Europe, USA, and Asia depending on the current location of the successful candidate. Specific locations can be discussed at point of application.
GSK make and supply medicines and vaccines all around the globe and our teams own every production stage, from creating quality products at our manufacturing sites to designing effective supply forecasting and regulatory inspections; all powered by digital, data and analytics. We operate at impressive scale, producing over 2.3 billion packs of medicines and doses of vaccines in 2022.
We are addressing gender equality at all levels within our organisation, we also remain committed to improving ethnic diversity within GSK and recruiting and developing talent that mirrors the communities in which we work. With support from our Global Disability Council and our employee resource group, the Disability Confidence Network, we are working hard to create an inclusive workplace.
We want GSK to be somewhere everyone can feel a sense of belonging and thrive. Our success absolutely depends on our people.
The Specialist, Specialty External Manufacturing Quality role supports the Biopharm Supply Chain products that are externally manufactured and tested to ensure they comply with GSK Quality expectations, specifications, and registered details. The Quality Specialist provides quality and regulatory support to ensure clinical/commercial manufacturing, new product introductions and transfers at external suppliers provide for a timely and reliable supply.
In this role you will…
Recommend and support implementation and continuous improvement of quality processes and procedures required to ensure GMP expectations for GSK external suppliers are met.
Build & maintain trusting relationship with external partners whereby influence can be applied & accepted to assure GSK quality standards are met.
Partner with key contacts at the External Supplier to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality.
Ensure quality and regulatory compliance for new product introductions and transfers by establishing liaisons and performing actions with GSK Regulatory groups and external suppliers to register and maintain product dossiers. Support compliance with QMS and cGMP requirements of external supplier via GMP Audit process.
Engage with External Supplier key contacts to ensure relevant and applicable outcomes from quality & manufacturing systems, such as batch records, deviations investigations, Change Controls, Validations, Annual Product Reviews (APRs), and product disposition are robust to ensure product quality.
Build & maintain good working relationships with internal partners, through compliance with applicable SOPs, Technical Terms of Supply and Service Level Agreement as applicable.
Why you?
Qualifications & Skills:
Degree in Science or Engineering discipline and significant experience in Manufacturing, QC, Engineering, Validation or Quality Operations.
Developing understanding of quality systems and quality control processes
Developing knowledge of GMP's, FDA, EU, and other regulatory agency requirements with an ability to apply to quality and compliance.
Developing knowledge of quality system principles and practical applications.
Developing knowledge and ability to apply quality and risk management principles and tools.
Developing knowledge of regulatory requirements including biological product and facility licensing requirements.
Preferred Qualifications & Skills:
MSc and some experience in Manufacturing, QC, Engineering, Validation or Quality Operations.
GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. Getting ahead means preventing disease as well as treating it, and we aim to positively impact the health of 2.5 billion people by the end of 2030.
Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a workplace where everyone can feel a sense of belonging and thrive as set out in our Equal and Inclusive Treatment of Employees policy. We’re committed to being more proactive at all levels so that our workforce reflects the communities we work and hire in, and our GSK leadership reflects our GSK workforce.
As an Equal Opportunity Employer, we are open to all talent. In the US, we also adhere to Affirmative Action principles. This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles. If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on Ukdiversity.recruitment@gsk.com or 0808 234 4391. Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels
As you apply, we will ask you to share some personal information which is entirely voluntary. We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions. We would really appreciate it if you could take a few moments to complete it. Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
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Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.
