Qualified Person
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.
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.
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.
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.
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.
The Ideal Candidate:
What You'll Do:
What You'll Need:
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QP qualified with at least 8 years’ experience on a license
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Solid experience in management of clinical trial supplies
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Experience in management of unlicensed/unauthorised medicines preferred
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Ability to be eligible for UK QP in the future would be an ideal candidate
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Significant hands-on experience with GMP manufacturing operations and batch certification activities
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Ability to influence decisions and effective communicator
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Ability to talk to clients confidently and understand their needs
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Ability to work on own initiative
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Adaptable and flexible towards work, using risk management effectively
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Strong site based experience in quality control, quality assurance or manufacturing operations
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