Responsible Person

Lever, Inc.; Dublin; On-site; EUR 55,000 - 75,000; Full time

Benefits offered by this job

Group Private Medical Insurance

Group Life Assurance

Pension Scheme

Enhanced Maternity & Paternity Pay

Educational Assistance

Paid Volunteering Day

Job summary

WEP Clinical is seeking a Responsible Person (RP) to ensure compliance with EU Good Distribution Practice and national regulations. This role is crucial for maintaining a quality management system and safeguarding the supply chain.

The ideal candidate will possess a Bachelor’s degree in pharmaceutical sciences or related fields, alongside significant experience in GDP settings. Strong communication skills and attention to detail are essential, as is the ability to manage various stakeholders

Qualifications

• Bachelor's Degree or higher in relevant fields.
• Significant experience with GDP setting preferred.
• Completion of Responsible Person training program.
• Extensive knowledge of GxP requirements.
• Knowledge of Good Distribution Practice regulations.
• Effective verbal and written communication skills.
• Proactive and solutions-driven.

Responsibilities

• Implement and maintain a quality management system.
• Participate in Quality Management Review Meetings.
• Assess and approve GDP Change Controls.
• Ensure training programs are maintained.
• Coordinate recall operations for medicinal products.
• Approve subcontracted activities impacting GDP.
• Perform self-inspections at regular intervals.

Skills

Strategic

Collaborative

Proactive

Adaptable

Communications

Decision Making

Organisational Skills

Critical Thinking

Attention to Detail

Education

Bachelor's Degree in pharmaceutical, life sciences, or engineering

Tools

Microsoft Office Suite

Job description

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 organisational, 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 individualswho 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/

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.

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