Description:
The purpose of this role is to ensure the timely and compliant release of clinical trial supplies in accordance with EU Good Manufacturing Practice (GMP) regulations. As a named Qualified Person (QP) on the site license, the incumbent will provide expert oversight and certification of investigational medicinal products (IMPs) — including small molecules, biologics, vaccines, and gene therapies — for use in clinical trials across Europe. This role supports the Quality Team by maintaining high-quality standards, ensuring regulatory compliance, and contributing to successful health authority inspections, audits, and global supply chain activities.
Responsibilities
- The QP will be involved in the review and certification of batches intended for use in clinical trials, to ensure compliance with EU GMP, the Product Specification File and the Clinical Trial Application.
- This role will encompass product manufactured across the company Global Supply Chain and subsequently imported into the EU. Products include Small Molecules, Large Molecules – Biologics, Vaccines, Gene Therapy etc
- The QP will be involved with Health Authority Inspections to maintain the site licences, audits both internal and external.
- This role will also be involved in ongoing compliance activities related to clinical trials, for example technical and quality agreements with collaborators, stock recovery activities etc.
- Ensure release of incoming goods, outsourced production/packaging products, and processes in full compliance with quality procedures, legal guidelines, and market authorization.
- Advise on and drive improvements for quality-related issues to ensure optimal product and process quality.
- Understand quality requirements for material introduction to the site and effectively communicate these requirements to suppliers.
Qualifications
- Eligible to be named as a Qualified Person (QP) and to have maintained CPD.
- A recognised pharmacy degree course at a third level institution in Ireland or if the pharmacy course has been completed outside of Ireland evidence of Pharmaceutical Society of Ireland registration and acknowledgement from the EU competent authority where the pharmacy degree was completed to meet the educational requirements of Article 49 of EU Directive 2001/83/EC and Article 97 of the EU Regulation 2019/6.
- Practical experience with disposition of product types such as Sterile, Nonsterile, Biologics, Vaccine, Gene Therapy or ATMP, is preferable.
- At least two year’s experience in quality assurance or qualitative analysis of related medicinal products.
- Familiarity with EudraLex Chapter 4, Annex 13, Annex 16 and applicable EU CTR regulations 536/2014.
- Extensive experience in a cGMP environment, preferably gained in a Quality function with respect to clinical trials/IMP environment.
- Experience with conducting audits and hosting inspections.
- Dynamic individual with excellent organizational skills, who can work effectively and proactively on global functional teams.