We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK

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.

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

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. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

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 place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

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. The helpline is available from 8.30am to 12.00 noon Monday to Friday, during bank holidays these times and days may vary.

Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels. However, we have created a UK Recruitment FAQ guide. Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .

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