Qualified Person (QP) - EU Importation Manager

1054 GlaxoSmithKline Services Unlimited; Irvine; Hybrid; GBP 40,000 - 65,000; Full time

Job summary

A leading pharmaceutical company is seeking a Qualified Person (QP) to join their Market Supply and Distribution team in Irvine. The role involves managing EU batch certification, ensuring compliance with GMP laws, and participating in regulatory inspections. Ideal candidates should possess strong interpersonal skills and relevant experience in batch release and Brexit processes.

Benefits

Competitive salary

Annual performance bonus

Training and professional development opportunities

Industry conference participation

Support for professional growth and certification

Healthcare and wellbeing programs

Recognition programs

Hybrid working model (post-training)

Qualifications

• Qualified Person (QP) with relevant experience in batch release.
• Knowledge of global and regional regulatory requirements.
• Experience with Brexit processes and GMP guidelines.

Responsibilities

• Manage EU/UK batch certification for imported pharmaceuticals.
• Ensure compliance and participation in regulatory inspections.
• Collaborate with R&D for new product imports.

Skills

Interpersonal skills

Continuous improvement mindset

Resilience

Education

Qualified Person (QP) qualification

Job description

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Qualified Person (QP) - EU Importation Manager, Irvine

Client:

1054 GlaxoSmithKline Services Unlimited

Location:

Irvine, United Kingdom

Job Category:

Other

-

EU work permit required:

Yes

Job Reference:

e0b88d04ab2e

Job Views:

5

Posted:

02.06.2025

Expiry Date:

17.07.2025

Job Description:

We’re excited to be moving to our new office on New Oxford Street in London from June 2024. At GSK HQ, we’re creating a space to connect, collaborate, and advance our mission to get ahead of disease. The new office will feature health-focused amenities, advanced technology, and bright workspaces.

We are seeking a Qualified Person (QP) to join our Market Supply and Distribution team. Reporting to a Quality Director, you will provide UK batch certification and release services for GSK’s Principal Trading Companies and partners, ensuring compliance with GMP laws for importation into the EU/UK. As part of the OQ team, you will make critical quality decisions independently, mentor colleagues, and support batch release activities, including managing deviations and incident responses. Regular interaction with cross-functional teams and stakeholders is essential, requiring integrity, respect, and transparency.

Key Responsibilities:

1. Manage operations for EU/UK batch certification of imported pharmaceutical products, supporting incident management.
2. Ensure QP Importation operations are inspection-ready and participate in regulatory inspections.
3. Audit the importation supply chain for GMP, GDP, and MIA compliance.
4. Certify all imported pharmaceutical batches in accordance with applicable laws and guidelines.
5. Coordinate with non-EU/UK manufacturing sites and external quality teams to maintain certification standards.
6. Collaborate with R&D for new product imports, ensuring timelines and certification activities are met.

Location - Please note: The role can be based at any UK GSK site (London, Barnard Castle, Ware, Worthing, Irvine, Montrose). Travel to Barnard Castle (about 3-4 times quarterly) is required for batch review and approval.

About You:

You should be a qualified QP with knowledge of global and regional regulatory requirements, GMP guidelines, and Brexit-related processes. You must handle complex issues with resilience and calmness, possess strong interpersonal skills, and have a continuous improvement mindset.

Closing Date: Friday, 5th July 2024 (COB)

Basic Qualifications:

• Qualified Person (QP) qualification
• Relevant experience in batch release, Brexit processes, and guidelines

Benefits:

• Competitive salary
• Annual performance bonus
• Training and professional development opportunities
• Industry conference participation
• Support for professional growth and certification
• Healthcare and wellbeing programs
• Recognition programs
• Hybrid working model (post-training)

Learn more about GSK benefits and culture on our webpage.

Why GSK?

GSK is committed to uniting science, technology, and talent to combat disease globally. We focus on vaccines, medicines, and innovative technologies in areas like infectious diseases, HIV, respiratory, immunology, and oncology.

Our success depends on our people. We aim to create an inclusive environment where everyone can thrive, feel valued, and grow. Join us at this exciting stage of our journey to get Ahead Together.

As an Equal Opportunity Employer, we consider all qualified applicants without regard to protected classes. We support flexible, agile working arrangements to accommodate individual needs.