Job Description

Site Name:

UK - County Durham - Barnard Castle

Posted Date:

Oct 23 2025

The Quality function promotes quality and compliance through the product life-cycle within the wider manufacturing and production operations at GSK Barnard Castle Manufacturing Site. The Quality function at GSK plays a critical role in ensuring our products meet the highest standards of safety, efficacy, and compliance. As part of this team you will uphold our commitment to delivering high-quality medicines and vaccines, and healthcare products to patients and consumers around the world.

Job Purpose:

Reporting into the site's Quality Compliance Lead, The Regulatory Inspection Senior Expert manages the Barnard Castle site's preparations and response efforts for regulatory inspections to ensure compliance with global standards and regulatory requirements.


This role acts as the primary liaison with regulatory authorities during inspections as well as driving implementation for corrective action and continuous improvement initiatives post-inspection. You will collaborate cross-functionally to maintain audit readiness, uphold Quality Management Systems (QMS) and ensure consistent compliance with industry standards.

Key Responsibilities:

Manage the site's preparation for regulatory inspections, ensuring all systems, processes, and documentation are audit-ready and compliant with global regulatory requirements. Act as primary point of contact during regulatory inspections. This includes facilitating interactions with inspectors and ensuring accurate and timely responses to queries. Coordinate cross-functional teams to address pre-inspection activities to ensure alignment across departments (and thorough preparation of inspection materials). Oversee development of inspection response plans for effective resolution of observations through robust corrective and preventive actions (CAPAs). Maintain site Quality Management System (QMS) to ensure consistent compliance with global standards and regulatory expectations. Monitor regulatory trends and changes, ensuring the site remains compliant with evolving requirements and standards. Provide training and guidance to staff on inspection readiness, regulatory expectations and best practices for interacting with inspectors. Collaborate with site leadership to embed a culture of compliance and continuous improvement across all operations. Benchmark site inspection practices against other GSK sites and industry leaders, implementing best practices to enhance audit readiness and compliance. Report inspection outcomes to site leadership, providing insights into trends, risks, and opportunities for improvement in regulatory compliance.

About You:

As this role is multi-faceted and includes liaising with a wide variety of on-site production and operations teams, you will be a self-motivated person who has strong experience of working in regulatory or quality functions and/or manufacturing at a complex highly-regulated manufacturing site. You should be able to demonstrate knowledge / experience of inspection readiness (audit-experience). You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance. You will have a strong continuous improvement mindset. Effective written and verbal communication and excellent interpersonal skills, as well as the ability to organise and prioritise workload are considered essential skills.

About Barnard Castle:

GSK Barnard Castle is a key secondary manufacturing site. We have invested heavily in industry 4.0 state of the art bespoke equipment to support sustained new product introductions and volume increases. As a key supplier of some of GSK's blockbuster products the site contributes revenues of ~$2Bn annually.

CLOSING DATE for applications: Wednesday 5th of November 2025.

Basic Qualifications:

Degree in relevant Scientific, Technical or Engineering discipline (or equivalent experience, ideally gained working in a Pharmaceutical Manufacturing Facility or similar highly-regulated industry). Relevant regulatory and inspection experience. Knowledge of current Good Manufacturing Practice (cGMP) requirements. Knowledge and application of Quality Management Systems (QMS). Knowledge of internal and external audit processes (eg; inspection readiness & validation).

Benefits:

GSK offers a range of benefits to its employees, which include, but are not limited to:

Competitive base Salary Annual bonus based on company performance Opportunities to partake in on the job training courses Opportunities to attend and partake in industry conferences Opportunities for support for professional development and chartership Access to healthcare and wellbeing programmes Employee recognition programmes

If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK.

Why GSK?

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

GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases - to impact health at scale.


People and patients around the world count on the medicines and vaccines we make, so we're committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.


GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.


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 UKRecruitment.Adjustments@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 .

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.


Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements. For more information, please visit the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/