Nom du site: UK – London – New Oxford Street, Belgium-Wavre, France - Evreux, France - Mayenne, GSK Aranda de Duero, Burgos, Mississauga Milverton Drive, UK - County Durham - Barnard Castle, UK - Hertfordshire - Ware, Upper Merion, USA - Maryland - Rockville, USA - North Carolina - Durham, USA - North Carolina - Zebulon
Data de publication: Jan 8 2025
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External Quality Regulatory Compliance Lead
Do you want to be a key asset for business transformation? Then this may be the role for you.
As the External Quality Regulatory Compliance Lead you get the opportunity to own and contribute to transformation projects for processes related quality and regulatory.
This a global role providing a lot of exposure, interfacing with multiple stakeholders and quality leadership team, which is great for visibility and future development.
We will be looking for this role to be based in the following locations: GSK House, Ware, Barnard Castle, Aranda, Evreux, Wavre, Mayenne, Rockville, Upper Merion, Zebulon, Mississauga, Durham
Job Purpose
The EQ Regulatory Compliance Lead role is responsible for key systems and processes for change control, regulatory conformance and compliance within External Quality. The role also develops, coordinates and provides an expert input into, regulatory strategies and compliance topics for the manufacture and registration of drug products and drug substances managed in external quality.
In this role you will...
- Be responsible for advising on regulatory compliance and conformance by the interpretation of registered details such as Preliminary Regulatory Advice as part of the change control assessment process, corporate standards, pharmacopoeial requirements, regulatory authority directives and commitments
- Provide consultancy on regulatory compliance and conformance topics
- Follow up on intelligence on new legislation and regulatory/pharmacopoeial requirements and provide an expert interpretation of impact to the business, and actively communicate this to the relevant stakeholders
- Own, maintain and improve the following processes and ensure input and alignment with the associated enterprise QMS documents: Quality change control process and linkage with Regulatory change control processes and systems (such as Veeva), the quality regulatory intelligence process, pharmacopoeial compliance process and associated tools within External Quality
- Ensure these processes and tools are in-use and manage the performance through metrics
- Deliver training as required
- Drive simplification and harmonisation across External Quality
- Act as interface between Central Regulatory Compliance and GRA and External Manufacturing team, in order to drive implementation of regulatory conformance and compliance requirements
Essential Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
- Degree in science or engineering or equivalent experience
- Significant experience in a Quality function within a highly regulated pharmaceutical environment
- Excellent prioritisation skills and ability to work in a complex environment
- Ability to work within a team to identify novel solutions to specific process and systems
- related issues
- Continuous improvement experience and/or certification
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
- Experience in change control processes and regulatory compliance processes
- Experience in the use of Veeva systems for applications of change control and regulatory documents
- Ability to influence with or without authority at all levels above and below own grade level
- Experience in Small Molecule products and Biologics or Vaccines products
Closing Date for Applications: Wednesday 29th January 2025
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements. The information that you have provided in your cover letter and CV will be used to assess your application.
GSK R&D
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people over the next 10 years. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. Science and technology are coming together in a way they never have before, and we have strong tech-enabled capabilities that allow us to build a deeper understanding of the patient, human biology and disease mechanisms, and transform medical discovery. We are revolutionising the way we do R&D. We’re uniting science, technology and talent to get ahead of disease together.
Find out more:
Our approach to R&D.
En tant que société animée par nos valeurs de concentration sur le patient, de transparence, de respect et d’intégrité, nous savons que l’inclusion et la diversité sont essentielles à notre réussite. Nous voulons que tous nos collègues s'épanouissent chez GSK en apportant leurs expériences uniques, en s'assurant qu'ils se sentent bien et en poursuivant leur carrière. En tant que candidat à un poste, nous souhaitons que vous partagiez le même sentiment.
Nous sommes ouverts à tous les talents - quels que soient votre sexe, votre handicap, votre état civil ou votre religion. ou conviction, âge, race, orientation sexuelle, origine ethnique ou nationale.
Nous croyons en une culture de travail agile pour tous nos rôles. Si la flexibilité est importante pour vous, nous vous encourageons à explorer avec notre équipe d'embauche les opportunités qui se présentent.
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