Qualified Person (QP)

About the role
This role is responsible for acting as a Qualified Person (QP) under UK and EU regulatory frameworks, ensuring that medicinal products released to the UK and EU markets fully comply with GMP, Marketing Authorisations, and applicable legislation. Reporting to the Quality Leadership Group in the UK, the position plays a critical role in batch certification, quality system oversight, regulatory compliance, and safeguarding patient safety across manufacturing and import activities.

What you will do

• Act as QP in accordance with UK law and EU Directive 2001/83/EC, ensuring full GMP and regulatory compliance

• Monitor and certify batch manufacturing and release activities for products manufactured or imported into the UK/EU

• Review quantitative and qualitative testing data, batch documentation, certificates, and reference sample retention

• Ensure compliance with Marketing Authorisations and EU/UK regulatory requirements for all released products

• Maintain and oversee quality documentation including QMRs, APRs, deviations, CAPAs, change controls, risk assessments, and self-inspections

• Drive and oversee the company Quality Management System and ensure alignment with corporate and local regulatory frameworks

• Act as the single point of contact for quality issues, regulatory inspections, deviations, and product recalls

• Liaise with regulatory authorities (including MHRA) and support manufacturing line and product approvals

• Guide senior management on quality, compliance, and regulatory risks impacting product quality and patient safety

• Oversee GMP training, SOP implementation, and continuous compliance across affected teams

• Act as QP for group entities following QP application approval

Requirements

• Eligibility to act as a Qualified Person under UK law (Directive 2001/83/EC)

• Minimum 4-5 years of experience acting as a QP in a pharmaceutical environment

• Degree in Pharmacy, Chemistry, Biology, or a related scientific discipline

• Extensive experience in pharmaceutical manufacturing and quality assurance

• Strong, hands-on knowledge of GMP, EU/UK pharmaceutical regulations, and quality systems

• Experience working within large pharmaceutical organisations

• High attention to detail, integrity, and strong decision-making capability

• Excellent communication skills with the ability to influence cross-functional and senior stakeholders

• Willingness to work fully onsite at a manufacturing or quality office environment

Benefits

• Critical, high-accountability role with direct impact on patient safety and regulatory compliance

• Opportunity to act as QP within a large, established pharmaceutical organisation

• Close collaboration with quality leadership, regulatory affairs, and manufacturing teams

• Exposure to complex UK and EU regulatory environments

• Stable, long-term position within a globally recognised pharmaceutical group

Diversity & Inclusion

We believe strong sales organizations are built on diverse perspectives, experiences, and leadership styles. We are committed to fostering an inclusive environment where individuals are valued for their expertise, ideas, and contribution and where equitable opportunities for growth and advancement are part of how we build high-performing teams.