Qualified Person (QP)

We are seeking a Qualified Person (QP) to join our QP Importation team. The role reports into the Quality Trading Partner QP Importation Director, and provides UK batch certification and release service to GSK’s Trading Partners. You will ensure compliance with the GMP aspects of the laws governing the importation of products into the UK in relation to all batch releases. As a member of the QP Importation Team you will be able to work with a degree of autonomy making critical Quality decisions whilst mentoring and supporting colleagues. In addition to undertaking regular batch release activities, you will provide direct support for critical deviations (including attending incident management meetings). The role will involve regular interaction with cross functional colleagues so stakeholder management, whilst acting with the highest level of integrity, respect and transparency is critical.

Responsibilities

• Ensure a compliant operation is in place to allow for QP certification pharmaceutical finished products batches imported into EU/UK.
• Identify, manage, resolve or escalate product issues or incidents that impact QP certification as required.
• Collaborate directly with the named Responsible Persons, MMW QPs, Global Logistics and Supply Chain Distribution to achieve resolution.
• Ensure QP Importation is inspection ready and front regulatory inspections of QP certification and other processes.
• Ensure oversight of the supply site operations via quality meetings with the site or GSK External Quality, involvement with site audits and visits to view operations as required.
• Support regulatory inspections of supply sites, as required.
• Be a lead point of contact with the GSK manufacturing sites, GSK External Quality and GMP Audit team for products manufactured outside the EU/ UK to ensure that the requirements for QP certification are in place and maintained.
• Actively represent QP Importation at Quality Councils and on assigned projects as required.
• Advise the wider GSK/ViiV organisation on the QP certification and regulatory requirements to ensure compliance.
• QP certify batches of medicinal products imported to the UK within the QP Importation portfolio.
• Maintain knowledge of legislation changes and proposals applicable to QP Certification, evaluate impact and propose mitigation for their compliant management and/or introduction.
• Provide oversight of the existing test arrangement to ensure EU/UK product testing requirements are met for all products imported into the EU/UK.
• Own and manage Quality Systems within QP Importation and the wider Trading Partner Quality Organisation.

Location

The role can be based at any GSK site in the UK (e.g.; GSK’s Head-quarters in London, Barnard Castle, Ware, Worthing, etc) but please note that there is a requirement to periodically travel to Barnard Castle (County Durham) periodically (as the need arises). It is anticipated that this will be circa 3 times a year.

About You

You will be a qualified QP (Qualified Person) who has sound knowledge of global, regional and national regulatory requirements and GMP guidelines (including risk management). Knowledge/experience relating to Brexit would be advantageous. You should be comfortable dealing with issues which may initially appear ambiguous or unclear and demonstrate an ability and willingness to help resolve complex problems as they arise. You will be resilient and calm under pressure with strong people skills. You will also have a strong continuous improvement mindset.

Basic Qualifications

• Qualified Person (QP) qualification.
• Relevant experience (e.g.; knowledge/experience of batch-release and Brexit-related process and guidelines).

What we value

We welcome people who bring curiosity, humility and a practical approach. We are committed to inclusion and to creating a supportive environment where everyone can grow. If you enjoy solving real problems, delivering measurable results, and helping teams succeed, we encourage you to apply.

Why GSK?

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. 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.