Job description
Site Name: UK - County Durham - Barnard Castle
Posted Date: Feb 11 2025
Quality Processes and Standards Lead
Closing Date for Applications – 25th February (COB)
This is an exciting opportunity to lead Quality Compliance activities at the Barnard Castle site. The Barnard Castle site is located in the North East of England within the County Durham countryside. Barnard Castle is a critical secondary site for GSK with many New Products coming through development from R&D. We manufacture and supply a huge range of different pharmaceutical products from Sterile Biological and Small Molecule Products to Liquid Inhalations and Dermatologicals. We have recently opened a new state-of-the-art aseptic digital facility focussed on producing GSKs pipeline of new biopharmaceuticals.
This role is accountable for the leadership of quality processes and standards across the site which include; Change Control, Data Integrity, Documentation, Internal and External Audits, Management Review, Regulatory Compliance and deployment of the GSK Quality Management.
The role will also be a key interface with other GSK sites, strategic product quality, central quality, technical teams, and R&D in ensuring the site is robustly adhering to quality compliance requirements, to share and learn best practices, and to always be inspection ready to host audits by regulatory authorities.
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
In this role you will:
* Leadership of new product registration and maintenance of existing licenses
* Responsible for the effectiveness of the Change Control process and associated activities
* Ensuring effectiveness of product quality compliance through the Periodic Product Review (PPR) process
* Ensure compliance with the GSK Quality Management System including Quality Alerts and Quality Bulletins.
* Data Integrity and GMP Documentation Standards
* Maintaining an independent programme of Internal Audits and a framework to ensure all parts of the site are always inspection ready
Why you?
Qualifications & Skills:
We are looking for professionals with these required skills to achieve our goals:
* Science degree with experience in Quality / Regulatory
* Extensive experience in Regulatory Inspections
* Senior stakeholder management experience
* Excellent knowledge of Quality, compliance and regulatory requirements for pharmaceutical products
* People management experience
Preferred Qualifications & Skills:
If you have the following characteristics, it would be a plus:
* Vocational qualification or training in Quality and or Regulatory
* Continuous improvement experience (e.g. Lean and Six Sigma)
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 .
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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