Qualified Person (QP)

1054 GlaxoSmithKline Services Unlimited; Harlow; Hybrid; GBP 45,000 - 70,000; Full time

Job summary

A leading biopharma company seeks a Qualified Person (QP) to join their Quality Assurance team at the Harlow site. The role involves providing certification and oversight for GMP processes, ensuring compliance with regulatory standards. Candidates must have a recognized QP qualification in the UK and experience in a sophisticated manufacturing environment.

Benefits

Annual bonus based on company performance

Opportunities for training and industry conferences

Access to healthcare and wellbeing programmes

Employee recognition programmes

Hybrid working model

Qualifications

• Qualified Person designation recognized in the UK.
• Experience in a manufacturing site.
• Experience with Clinical Phase 1 units is a plus.

Responsibilities

• Provide Qualified Person certification and GMP oversight of batches.
• Support QMS activities at Phase I unit.
• Ensure compliance operations for Investigational Medicinal Products.

Skills

Qualified Person (QP)

GMP oversight

Strong communication skills

Education

Qualified Person qualification

Job description

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We have a new opportunity for a Qualified Persons (QPs) to join our Quality Assurance (QA) team at our Harlow site primarily supporting the Phase I unit at CUC Addenbrookes, Cambridge. As a QP you will also perform the quality assurance activities and quality oversight of the GMP functions performed within Pharmaceutical Research & Development processes (including batch-release for manufactured product for clinical trial purposes).

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

In this role you will

• Provide Qualified Person certification and GMP oversight of batches manufactured at the GSK Phase I unit at Addenbrookes Hospital, Cambridge (approx. 50% role)
• Provide QP advice and oversight of QMS activities and GMP compliance at the Phase I unit and to GSK business partners supporting the facility.
• Perform Qualified Person certification (as defined in EU directive 2001/20/EC, regulation 536/2014, Article 51 of Directive 2001/83/EC and UK equivalents) and perform QP release of a range of primary and secondary packed Investigational medicinal products. (approx. 50% role)
• Ensure compliant operations are in place to allow for UK certification of batches of Investigational Medicinal Products and assure products meet regulatory requirements.
• Maintain knowledge of legislation changes applicable to QP Certification (including evaluate impact and propose mitigation for compliant management and/or introduction).
• Build and maintain internal and External business relationships (communicating and interacting at various levels internally and externally). Incorporate effective processes in Product Quality Pharma R&D to provide oversight of manufacturing facilities (pilot plant and/or clinical packaging and distribution).
• Participate in/host regulatory audits and support internal audits/investigations (eg; Quality Investigations, customer complaints and vendor complaints) and recommend corrective and preventative actions (and follow up on the implementation of those recommendations).

About You:

You will be a Qualified Person (QP) – this is key to delivery in this role. Your QP qualification must be recognized in the UK.

As this role is multi-faceted and collaborates with a wide variety of on-site production and operations teams, you will also be self-motivated with strong experience of working in quality at a sophisticated manufacturing site. You will be resilient and calm, with strong communication skills.

Basic Qualifications & Skills:

We are looking for professionals with these required skills to achieve our goals:

• Qualified Person (QP) - stated on a current UK Manufacturer’s/Importer’s licence
• Relevant experience on a manufacturing site (preferably IMP)

Preferred Qualifications & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

• Experience of Clinical Phase 1 units and batch release within these facilities

Closing Date for Applications – 20th July 2025 (COB)

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

• Annual bonus based on company performance
• Opportunities to partake in on the job training courses
• Opportunities to attend and partake in industry conferences
• Access to healthcare and wellbeing programmes
• Employee recognition programmes
• Hybrid (onsite/remote) working within GSK policies (post training period)

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.

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.