Qualified Person – Clinical Trials Pharmacist

About the role

We are seeking a Qualified Person (QP) to join our growing CRO and take responsibility for the certification and release of investigational medicinal products (IMP) used in human clinical trials. The role will be based in Leeds or Manchester and will involve travel between sites to ensure compliance across all locations.

Key responsibilities

• Release IMP for use in clinical trials, ensuring compliance with the MIA IMP licence and Directive 2001/20/EC Article 13.
• Review and approve Technical Quality Agreements, Master Batch Records, Annex 13 documents, production and pharmacy manuals, and related study documentation.
• Assess CTA, Annex 13 labels, IMPDs and other submission documents for regulatory compliance.
• Maintain Product Specification Files and Pharmacy Files for each study.
• Review and sign batch records, issue QP certifications, and record batch releases in the QP batch register.
• Manage product complaints, deviations, and recalls.
• Ensure the Quality Management System supports safe IMP manufacture and release.
• Maintain professional qualifications and engage in continuous professional development.

Required profile

• Degree in Pharmacy, Biological or Chemical Sciences.
• Member of a recognised professional body (e.g., Royal Pharmaceutical Society, Royal Society of Chemistry, Institute of Biology).
• Minimum two years’ experience in clinical trials within the pharmaceutical industry.
• Eligibility to act as a Qualified Person and be named on the MIA IMP licence.
• Experience in a CRO, Phase‑1 unit or hospital pharmacy is desirable.

Required skills

• IMP certification and release procedures.
• Good Clinical Practice (GCP) compliance.
• Good Manufacturing Practice (GMP) compliance.
• Review of batch records and QP certification documentation.
• Quality Management System implementation.

What we offer

• Competitive salary aligned with the pharmaceutical sector.
• Opportunities to work across multiple sites and develop a broad professional network.
• Support for continuous professional development and maintaining professional registration.
• Dynamic, progressive work environment within a leading CRO.