Qualified Person

Qualified Person (QP) – Sterile / Biologics Manufacturing

Deeside, North Wales, UK

Permanent Position

We are supporting the appointment of an experienced Qualified Person (QP) at a highly specialised pharmaceutical manufacturing facility based in Deeside, North Wales .

The site focuses on advanced antibody, protein and peptide drug conjugate technologies , operating within one of the fastest-growing areas of oncology therapeutics. The facility supports development activities from discovery through to clinical development within a state-of-the-art environment designed for highly potent bioconjugation processes.

The Role

The Qualified Person will be responsible for performing the full duties of a QP in line with EU and UK regulatory frameworks, ensuring compliant certification and release of medicinal products and investigational medicinal products (IMPs).

This role sits within the Quality function and will play a key role in maintaining regulatory compliance, supporting product release and providing strategic quality oversight across the site.

Key Responsibilities

• Act as a Qualified Person in accordance with Eudralex Volume 4 Annex 16 and EU Directive 2001/83 as incorporated into UK law

• Review and certify batch manufacturing and testing documentation for product release

• Support the release of Investigational Medicinal Product (IMP) batches

• Ensure compliance with GMP requirements and relevant regulatory expectations

• Manage and review quality system elements including deviations, CAPAs and change controls

• Provide GxP guidance and support across site functions

• Interface with regulatory authorities and customers as required

• Ensure correct documentation and regulatory frameworks are in place for product certification

• Contribute to the development of site and group quality strategy

Candidate Profile

• Eligible to act as a Qualified Person under UK legislation

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

• Minimum 10 years’ experience working in GxP environments within the pharmaceutical or biologics sector

• Extensive experience interacting with regulatory authorities

• Strong knowledge of GMP regulations and pharmaceutical quality systems

• Experience within sterile, biologics, or complex manufacturing environments preferred

• Strong leadership, communication and stakeholder management skills