Are you seeking an exciting and fulfilling new opportunity? Join our dynamic team at WEP Clinical, where your contributions will play a key role in driving impactful solutions and improving outcomes for clients and patients. We encourage innovation and collaboration, challenging our team to bring forward ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.

Role Objectives:

The Qualified Person (QP) is accountable for ensuring that all medicinal products handled, packaged, released, and distributed from the Dublin facility, as part of WEP Clinical’s broader GMP operations, comply with applicable EU GMP and relevant regulatory requirements.

The QP will be responsible for batch certification of unlicensed medicines and investigational medicinal products intended for clinical trial, ensuring patient safety, product quality, and regulatory compliance. The role also supports core GMP quality operations across WEP Clinical activities and contributes to inspection readiness, quality oversight, and the continued development of GMP capabilities to support operational growth.

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The Ideal Candidate:

Team Player
Communicative
Problem Solver
Detail-oriented

What You'll Do:

Perform QP duties in accordance with EU GMP (Annex 16), EU Directives/Regulations, and Irish legislation.
Certify medicinal products including IMPs, AMPs, and unauthorised/exempt medicines.
Ensure QP certification aligns with EU GMP, EU Clinical Trials Regulation/Directive, IMPDs, PSFs, protocols, local authorisations, and Quality Agreements.
Perform and document import GMP verification for products from third countries.
Ensure products are manufactured to EU/EEA GMP standards and regulatory expectations.
Verify supply chain compliance in line with approved Quality Agreements.
Maintain the QP Register for Compassionate Use and Clinical Trial batches.
Review supply chain, product-level, and batch-level documentation (e.g. audit reports, IMPDs, validation data, batch records, transport records).
Support development and approval of Product Specification Files (PSFs).
Oversee manufacturing, packaging, testing, and importation activities, including outsourced operations.
Review and approve Quality Technical Agreements and support QMS activities (deviations, CAPAs, change controls, complaints).
Support inspections (including HPRA), client interactions, and drive continuous improvement in GMP and QP release processes

What You'll Need:

QP qualified with at least 8 years’ experience on a license
Solid experience in management of clinical trial supplies

Experience in management of unlicensed/unauthorised medicines preferred

Ability to be eligible for UK QP in the future would be an ideal candidate

Significant hands-on experience with GMP manufacturing operations and batch certification activities

Ability to influence decisions and effective communicator

Ability to talk to clients confidently and understand their needs

Ability to work on own initiative

Adaptable and flexible towards work, using risk management effectively

Strong site based experience in quality control, quality assurance or manufacturing operations

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What We Offer:

Private healthcare insurance

Long-term illness Cover

Death in service cover

Salary sacrifice pension

Annual leave

Paid maternity & paternity leave

Volunteer day

What Sets Us Apart:

WEP Clinical partners with sponsors to help patients and physicians gain early access to medicines when no other treatment options are available. WEP Clinical has over 15 years of experience distributing products to over 120 countries worldwide to treat unmet patient needs.

We're Committed to Our Team:

WEP has many initiatives to encourage wellness, growth, development, and team relationships. Check out our LinkedIn Life Page to learn more about our team events and all we do to support our employees.

We're Committed to DEI:

At WEP Clinical, acceptance, recognition, and engagement are the core of our DEI values. We are committed to giving employees opportunities for personal and professional success and growth and to embracing everyone's unique identities.

Our services include:

Access Programs

Clinical Trial Services

Patient Site Solutions

Clinical Trial Supply

Market Access and Commercialisation

WEP Clinical is a smoke-free, drug-free, and alcohol-free work environment.

WEP Clinical is an equal-opportunity employer. WEP Clinical does not unlawfully discriminate against employees or applicants for employment based on an individual’s race, colour, religion, creed, sex, sexual orientation, gender identity or expression, national origin, genetic information, age, disability, marital status, veteran status or any other status protected by applicable law. This policy applies to all terms, conditions, and privileges of employment, including recruitment, hiring, placement, compensation, promotion, discipline, and termination. WEP Clinical will make reasonable accommodation for qualified individuals with known disabilities, in accordance with applicable law.

Qualified Person

Benefits

Job Description