Eq Regulatory Compliance Lead

**Site Name**: 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
**Posted Date**: 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
- 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.

**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 ta