Qualified Person (QP) - EU Importation Manager

TN United Kingdom; North East; Hybrid; GBP 40,000 - 70,000; Full time

Job summary

A leading biopharma company is seeking a Qualified Person (QP) to join their Importation team. This role involves batch certification, ensuring compliance with regulatory requirements, and managing operations for imported pharmaceutical products. The ideal candidate will have a QP qualification, strong problem-solving skills, and experience with GMP guidelines. The position offers a competitive salary, annual bonus, and opportunities for professional development in a hybrid working environment.

Benefits

Competitive salary

Annual bonus

Training courses and industry conferences

Support for professional development

Healthcare and wellbeing programs

Recognition programs

Hybrid working (onsite/remote) post-training

Qualifications

• Experience with batch release and Brexit-related processes is advantageous.
• Strong people skills and a continuous improvement mindset are essential.
• Ability to resolve complex issues and remain calm under pressure.

Responsibilities

• Manage operations for EU/UK certification of imported pharmaceutical batches.
• Ensure QP Importation operation is inspection-ready and participate in regulatory inspections.
• Certify all batches of imported pharmaceutical products into the UK.

Skills

Regulatory knowledge

GMP guidelines

Stakeholder management

Problem-solving

Risk management

Education

Qualified Person (QP) qualification

Job description

Job Description:

We’re excited to be moving to our vibrant new home on New Oxford Street in central London from the end of June 2024. At GSK HQ, we’re building an energising space where we can connect, collaborate, and get ahead of disease together. Designed especially for us, it’ll be one of the healthiest workplaces in the world, with best-in-class tech and bright, light spaces to help us thrive.

We are seeking a Qualified Person (QP) to join our QP Importation team in Market Supply and Distribution. The role reports into a Quality Director and provides UK batch certification and release service to GSK’s Principal Trading Companies (PTCs) and Trading Partners. You will ensure compliance with GMP laws governing the importation of products into the EU/UK. As part of the OQ team, you will work with a degree of autonomy, making critical quality decisions while mentoring colleagues. You will undertake regular batch release activities and support critical deviations, including attending incident management meetings. The role involves regular interaction with cross-functional colleagues, so stakeholder management and acting with integrity, respect, and transparency are critical.

Key Responsibilities:

1. Managing operations to allow EU/UK certification of imported pharmaceutical batches, supporting incident management to ensure supply sites have necessary information for investigations and resolution.
2. Ensuring QP Importation operation is inspection-ready and participating in regulatory inspections of the certification process.
3. Performing audits of the importation supply chain (compliant with GMP, GDP, and MIA authorization).
4. Certifying all batches of imported pharmaceutical products into the UK in accordance with applicable laws and guidelines (e.g., EU GMP Part 1, Annex 16).
5. Acting as a key contact with non-EU/UK manufacturing sites and external quality teams to maintain QP certification requirements.
6. Collaborating with R&D for new products, ensuring testing locations are identified, and certification activities meet timelines.

Location - Please note:

The role can be based at any GSK UK site (London, Barnard Castle, Ware, Worthing, Irvine, Montrose, etc.), with travel to Barnard Castle (County Durham) approximately 3-4 times per quarter for batch review and approval.

About You:

You will be a qualified QP with knowledge of regulatory requirements and GMP guidelines, including risk management. Experience related to Brexit is advantageous. You should be comfortable resolving complex issues, resilient, calm under pressure, and possess strong people skills. A continuous improvement mindset is essential.

Closing Date:

Friday, 5th July 2024 (COB)

Basic Qualifications:

• Qualified Person (QP) qualification.
• Relevant experience, including knowledge of batch release and Brexit-related processes.

Benefits:

• Competitive salary
• Annual bonus
• Training courses and industry conferences
• Support for professional development
• Healthcare and wellbeing programs
• Recognition programs
• Hybrid working (onsite/remote) post-training

Learn more about our company benefits and life at GSK on our webpage.

Why GSK?

GSK is a global biopharma company committed to uniting science, technology, and talent to get ahead of disease. We focus on vaccines, medicines, and the immune system, investing in key therapeutic areas. Our success depends on our people, and we aim to create an inclusive environment where everyone can thrive. Join us at this exciting moment in our journey to get Ahead Together.

As an Equal Opportunity Employer, we welcome all talent and adhere to Affirmative Action principles in the US. We promote an agile working culture and encourage exploring flexible working arrangements with our hiring team.