Description

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

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

The Sterility Assurance Subject Matter Expert ensures product quality and safety by overseeing sterility assurance programs, encompassing aseptic processes and microbiological standards, while ensuring compliance with regulatory requirements.

In this role you will…

• Lead and manage sterility assurance within area of expertise to ensure compliance with regulatory requirements and alignment with contamination control, microbiological standards, and aseptic processes.
• Act as the site technical expert for sterility assurance, providing guidance and support across sterility-related areas, including aseptic processing, environmental monitoring, and microbiological controls.
• Identify gaps and drive continuous improvement of sterility assurance practices by implementing enhancements and best practices to optimise contamination control measures.
• Ensure compliance with Quality Management Systems (QMS) and drive implementation across manufacturing, operations, and quality teams to maintain compliance and improve performance.
• Develop and deliver training programmes, ensuring staff understand and consistently apply sterility assurance and contamination control measures.
• Provide technical expertise during internal and external audits, serving as the sterility assurance SME to ensure compliance with regulatory and corporate standards.
• Collaborate with GSK's sterility assurance expertise network to harmonise practices, share knowledge, and contribute to the continuous improvement of sterility assurance across the organisation.
• Support site readiness for audits and inspections by ensuring robust systems are in place and providing expert input during regulatory reviews.

Why you? 

Basic Qualifications & Skills:

• Bachelor's degree in Chemistry, Biochemistry, Microbiology, or a related field.
• Significant experience in sterility assurance within the pharmaceutical, biotechnology, or related industry.
• Strong knowledge of regulatory requirements related to sterility assurance and sterile manufacturing (e.g., FDA, MHRA, EMA) and industry standards (e.g., cGMP, ISO).
• Excellent problem-solving skills and attention to detail.
• Strong leadership and project management abilities.
• Effective communication and interpersonal skills

Preferred Qualifications & Skills:

• Advanced degree in Chemistry, Biochemistry, Microbiology, or a related field.

Closing Date for Applications: 7th November 2025 (COB)

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 above. The information that you have provided in your cover letter and CV will be used to assess your application.

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

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