The Role
Oversee compliance with EU Good Distribution Practice, national regulations, and wholesaler authorization requirements. Maintain the quality management system, approve GDP procedures and changes, oversee deviations and CAPAs, manage training, recalls, complaints, supplier and customer approvals, subcontracted activities, and self-inspections. Decide on product disposition and ensure accurate records and regulatory compliance. The role may also serve as Deputy Responsible Person for the UK and provide line management.
Summary Generated by Built In
Are you looking for an exciting and fulfilling new position? 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 ideas that make a real difference. Be part of a mission-driven organisation dedicated to advancing clinical research and transforming lives.
Role Objectives:
The Responsible Person (RP) is an integral role within the company to ensure that EU Good Distribution Practice, national regulations, and provisions listed on the Wholesalers Distribution Authorisation are met and complied with at the company. The objective is to assure quality, safety, and traceability throughout the supply chain in order to protect end-users from harm. This is done by ensuring that an effective Quality Management System is maintained with oversight from the RP.
The Ideal Candidate:
- Strategic
- Collaborative
- Proactive
- Adaptable
What You'll Do:
- Ensure a quality management system is implemented and maintained, including the review and approval of GDP procedures, and remain continually contactable as the RP.
- Ensure the principles of Quality Risk Management are applied to all RP duties and responsibilities, and that obligations to the Falsified Medicines Directive are met.
- Participate in Quality Management Review Meetings, ensuring minutes are taken and actions are brought to closure in a timely manner.
- Assess and approve GDP Change Controls, with oversight of Deviations and CAPAs (Action Items) as appropriate.
- Focus on the management of authorised activities and the accuracy and quality of records.
- Ensure initial and continuous training programmes are implemented and maintained, and keep up to date with legislative changes and ongoing training as identified.
- Coordinate and promptly perform any recall operations for medicinal products, and ensure relevant customer complaints are dealt with effectively.
- Ensure that suppliers and customers are approved.
- Approve any subcontracted activities that may impact GDP, including contracts between the contract giver and acceptor specifying their respective responsibilities for wholesaling activities such as storage, distribution, and transportation of medicinal products.
- Ensure self-inspections are performed at regular intervals following a prearranged programme, with necessary corrective measures put in place.
- Decide on the final disposition of returned, rejected, recalled, or falsified products, approve any returns to saleable stock, and ensure any additional requirements imposed on certain products by national law are adhered to.
- Delegate duties when absent and keep appropriate records of any delegation, and provide line management as needed, including setting clear objectives, supporting development, and managing performance.
- May take on the responsibility as the Deputy RP for the UK .
What You'll Need:
- Bachelor's Degree or higher (preference for pharmaceutical, life sciences, or engineering concentration)
- Significant experience and demonstrated industry knowledge (preference for GDP setting)
- Completion of the Responsible Person training program and/or refresher program
- Extensive knowledge of GxP requirements, including but not limited to GMP, GDP, and GCP for EU/FDA/WHO, and appropriate regional research regulations and guidelines
- Extensive knowledge of Good Distribution Practice national regulations and associated guidelines, with the ability to interpret legislation and assess requirements
- Effective verbal and written communication skills, with strong interpersonal skills
- Ability to use initiative, think critically, and make effective decisions
- Pro-active and solutions-driven, with the ability to work to strict deadlines with a high level of accuracy
- Strong organizational, planning, and administrative skills, with attention to detail and high self-motivation
- Ability to work proficiently within the Microsoft Office Suite, including Word, Excel, and PowerPoint
What We Offer:
Group Private Medical Insurance
Group General Life Assurance
Group Critical Illness and Group Income Protection
Salary sacrifice pension scheme
Enhanced maternity & paternity pay
Educational Assistance allowance
Paid volunteering day
What Sets Us Apart:
WEP Clinical partners with biopharmaceutical Sponsors to help them bring treatments closer to the patients who need them most. Through end-to-end clinical trial delivery, home health services, expanded access programs, and market access consultancy, we provide flexible, fit-for-purpose solutions that support drug development, improve access, and help therapies reach the right patients at the right time. With more than 15 years of global experience, we have supported programs across 150+ countries, combining operational scale with the agility and personalised service of a specialised provider. Our work helps bridge critical gaps in care, ensuring safe, ethical, and efficient access to promising new treatments.
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 that we do to support our employees.
How We Work at WEP Clinical:
At WEP Clinical, we look for individuals who are conscientious, exercise sound judgement, and engage with others thoughtfully and professionally. We believe excellence is achieved through integrity, accountability, and respect for diverse perspectives – and we are committed to helping our people grow and succeed in an inclusive, supportive environment.
Our Services Include:
Access Programs
Clinical Trial Services
Patient Site Solutions
Clinical Trial Supply
Market Access and Commercialisation
Data Privacy Notice:
WEP Clinical is committed to protecting your personal information throughout the recruitment process. By applying, you acknowledge that your personal data will be processed in accordance with our Privacy Policy and Job Applicant Privacy Notice.
Privacy Policy: https://www.wepclinical.com/privacy-policy/
Job Applicant Privacy Notice: https://www.wepclinical.com/Job-Applicant-Privacy-Notice/
How to Apply:
To be considered for this role, please submit your resume through the WEP Clinical Careers Portal or by using LinkedIn’s Easy Apply option. Please ensure your resume is in English.
Important Note:
To streamline our hiring process, we use an Upwage AI screener. If you receive a link from Upwage, it is a legitimate part of our application process and helps ensure every candidate is reviewed consistently. If you are selected to move forward after the screener, a member of our team will contact you directly from an @wepclinical.com email address to guide you through the next steps of the interview process. Please ensure you apply only through our official careers page (https://www.wepclinical.com/careers/) or our verified LinkedIn page.
For Your Safety, Please Note:
We will never communicate with you via Microsoft Teams or text message
We will never ask for your bank account information at any stage of recruitment.
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.
#LI-fulltime #LI-onsite
Skills Required
- Bachelor’s degree or higher
- Degree concentration in pharmaceutical, life sciences, or engineering
- Significant industry experience and demonstrated industry knowledge
- Experience in a Good Distribution Practice setting
- Completion of Responsible Person training and/or refresher training
- Extensive knowledge of GxP requirements, including GMP, GDP, and GCP for EU, FDA, and WHO regulations
- Knowledge of applicable regional research regulations and guidelines
- Extensive knowledge of Good Distribution Practice national regulations and associated guidelines
- Ability to interpret legislation and assess regulatory requirements
- Effective verbal and written communication skills
- Strong interpersonal skills
- Ability to use initiative, think critically, and make effective decisions
- Proactive, solutions-driven approach and ability to meet strict deadlines accurately
- Strong organizational, planning, and administrative skills with attention to detail
- High level of self-motivation
- Proficiency with Microsoft Office Suite, including Word, Excel, and PowerPoint
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The Company
What We Do
We are a rapidly growing niche pharmaceutical services company operating in four key sectors:- Managed Access Programs (MAP) Unlicensed Medicines Access Clinical Trial Sourcing Reference Product Supply. Our goal is to provide positive measurable outcomes to patients and sponsors but above all else we want to be known as your “trusted partner” and an extension of your team. •UK headquarters established in London in 2008. •US Headquarters established in Research Triangle Park, North Carolina in 2012. •Our team has many years of pharmaceutical, clinical and regulatory experience gained in companies such as Pfizer, AZ, MSD, GSK, UDG Healthcare, Waymade, Sanofi, Quintiles & Walgreens Boots Alliance. •Our facilities have been inspected & licensed by the MHRA, UK Home Office, FDA and all necessary local approval bodies. •We are also approved to handle and distribute controlled substances. •We are compliant with all relevant GMDP regulations and operate to a high standard of medicines supply. •We operate under a comprehensive Quality Management System with robust and compliant standard operating procedures (SOPs) and policies. •Our customers and partners include Pharma, Biotechs, Generic and Biosimilar Developers, CROs and Healthcare and Hospital authorities. •We are fully committed to a culture of continual development and strive to service our partners needs beyond their expectations We would be happy to answer any questions that you may have regarding WEP Clinical and our products and services.
