We have a new opportunity for a Qualified Person (or trainee QP close to eligibility) to join our team on a permanent basis at Harlow. The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D.
You’ll provide expert oversight, certification, and release of products, ensuring they meet regulatory standards and support GSK’s mission to get ahead of disease together. Collaborating with cross-functional teams and external partners, you’ll contribute to innovation, continuous improvement, and patient safety. This is an opportunity to grow your career, make a meaningful impact, and be part of a team that values inclusion, integrity, and excellence.
In this role you will…
1. Provide QP certification and release investigational medicinal products in compliance with EU and UK regulations.
2. Ensure compliant operations to meet regulatory standards, guaranteeing product quality and conformity to submissions.
3. Stay ahead of legislative changes, assess their impact, and implement mitigation strategies.
4. Offer expert QP advice to internal teams, external collaborators, and sponsors, reducing regulatory risks and ensuring critical assurances.
5. Build strong relationships across GSK and with external partners, contributing to process improvements and mentoring others within the organization.
6. Participate in audits, investigations, and quality reviews, recommending and implementing corrective actions where necessary.
Basic Qualifications
7. Science degree and extensive experience in pharmaceutical manufacturing and quality operations.
8. Eligible to act as Qualified Person in the UK (or imminently ready to submit for Viva)
9. Extensive experience working alongside QP’s certifying major dose forms such as Tablets, aseptic sterile manufacture and biopharm products
10. Broad knowledge of quality management
11. Capable of working in multi-disciplinary teams
Preferred Qualifications/ Experience
12. Previous experience of working with external partners.
13. Experience in QP certification of Investigational Medicinal products.
14. Experienced of Regulatory Inspections
15. Certification of Investigational Medicinal Products
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.