Associate Director, Responsible Person (Ireland)
Location: Remote- UK and Ireland
Contract Type: 18-month Contract
IR35- Inside
Are you a seasoned Responsible Person (RP) with a passion for quality and regulatory excellence?
Our client is seeking an Associate Director, Responsible Person (Ireland) to lead quality compliance and Good Distribution Practice (GDP) initiatives for our Ireland Affiliate.
As the RP, you will play a pivotal role in ensuring compliance with GDP and GxP standards while overseeing their distribution network and driving strategic quality assurance (QA) initiatives. You will also represent the client in regulatory inspections and support wider regional and global quality projects.
Key Responsibilities:
Act as the Responsible Person (RP) on Wholesale Distribution Authorisation (WDA), ensuring full compliance with HPRA and EU GDP guidelines.
Lead quality management system (QMS) implementation and maintenance, ensuring best practices are upheld.
Drive quality initiatives related to distribution network improvements.
Manage regulatory inspections, audits, and compliance activities, including CAPA implementation and engagement with Health Authorities.
Approve GDP-related activities such as supplier and customer qualifications, subcontracting approvals, and product recalls.
Ensure continuous training and development for GDP-related activities.
Oversee risk management activities and support decision-making on product quality matters.
What We’re Looking For:
✅ Specialised expertise in GDP regulations (EU & Ireland), with broad knowledge of GMP and GVP requirements.
✅ Proven experience as an RP on a European WDA.
✅ Strong leadership and communication skills, with the ability to influence and collaborate cross-functionally.
✅ Demonstrated experience in quality auditing (GDP & GMP).
✅ Skilled in regulatory compliance, risk management, and stakeholder engagement.
✅ Ability to manage regulatory inspections and implement robust CAPA strategies.
✅ Excellent organizational, analytical, and technical writing skills.
Education & Experience:
Bachelor’s degree in a scientific or allied health field (or equivalent).
Relevant experience in GDP, GMP, and regulatory compliance within the pharmaceutical industry.
Why Join?
Global Impact: Work with a company dedicated to transforming patient lives through innovation.
Leadership Opportunity: Be the driving force behind quality and compliance in Ireland.
Collaborative Culture: Join a dynamic, cross-functional team in a forward-thinking environment.
Ready to take the next step in your career? Apply now and be part of our mission to advance healthcare excellence!