Qualified Person (QP) Senior Lead

Position Summary

We are looking for a Qualified Person (QP) Senior Lead to join our QP Importation team in Ireland. This role is an exciting opportunity to make a meaningful impact by ensuring the highest standards of quality and compliance in pharmaceutical manufacturing. The role involves EU batch certification and release and ensuring compliance with the GMP aspects of the laws governing the importation of products into the EU. 

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

Responsibilities

• Ensure a compliant operation is in place to allow QP certification of batches of pharmaceutical products.
• QP certify all batches of Pharma products imported into EU in accordance with the requirements of EU Guidance on GMP Part1, Annex 16 and Annex 21.
• Ensure the QP Importation operation is inspection ready and lead/host regulatory inspections of the QP certification process.
• Ensure oversight of supply site operations via formal quality meetings with the site, involvement with internal audits undertaken at the sites and visits to view operations as required. 
• Support regulatory inspections of supply sites, as required.
• Perform audits of the importation supply chain to ensure compliance with GMP, GDP and MIA authorisation, as required.
• Actively represent QP Importation on assigned projects, as required.
• Mentor and coach junior members of the team.

Qualifications/Skills

Basic Qualifications:

• Scientific degree
• Significant experience in pharmaceutical manufacturing and quality operations
• Experience with the certification of major dose forms (tablets, cream/ointments), aseptic sterile manufacture and biopharm products
• Experience in management of Manufacturer Importation licences
• Knowledge of GDP regulations

Closing Date for Applications – 07 Sep 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.

We manufacture and supply reliable, high-quality medicines and vaccines to meet patients’ needs and drive our performance.

Our network of 37 medicines and vaccines manufacturing sites delivered 1.7 billion packs of medicines and 409 million vaccine doses in 2024 to help make a positive impact on the health of millions of people. Our supply chain is not just core to our operations; it’s vital to bringing our innovations to patients as quickly, efficiently and effectively as possible. Technology is transforming how we manufacture medicines and vaccines, enabling us to increase the speed, quality and scale of product supply.

We need the very best minds and capability to help us on our journey to make more complex products, harnessing the power of smart manufacturing technologies including robotics, digital solutions and artificial intelligence to deliver for patients.

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