Qualified Person (QP) in Worthing

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.

Key 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 elevate 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 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 (eg; 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.

Basic Qualifications

• Qualified Person (QP) qualification.
• Relevant experience (eg; 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. 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 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.

Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us at UKRecruitment.Adjustments@gsk.com where you can also request a call.