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 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 practices; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
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 to quality and regulatory.
This is a global role providing a lot of exposure, interfacing with multiple stakeholders and the quality leadership team, which is great for visibility and future development.
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 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 interpreting 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 regarding new legislation and regulatory/pharmacopoeial requirements and provide an expert interpretation of the impact on the business, actively communicating 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 performance through metrics.
Deliver training as required.
Drive simplification and harmonization across External Quality.
Act as an interface between Central Regulatory Compliance and GRA and the External Manufacturing team 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 prioritization 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 provide 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.
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 organization 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.
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