Responsible Person

Walker Cole International is partnered with a pharmaceutical business in Malta to identify a Responsible Person (RP) for its growing Quality function. 

Reporting into senior Quality leadership, this position is responsible for ensuring GDP compliance across wholesale distribution operations while supporting the ongoing development of the company's Quality systems. Alongside acting as the Responsible Person, you will help to strengthen internal Quality capability and reduce reliance on outsourced support.

As the Responsible Person, your responsibilities will include:

• Providing oversight of GDP compliance across wholesale distribution activities, ensuring products are handled, stored and supplied in accordance with regulatory expectations.
• Leading the development and continual enhancement of the Quality Management System, maintaining robust procedures and a constant state of inspection readiness.
• Managing supplier qualification, internal audits, third-party oversight and supporting regulatory inspections from Competent Authorities.
• Driving investigations relating to quality events, including deviations, complaints, returns, recalls and product quality issues, ensuring appropriate corrective actions are implemented.
• Working cross-functionally to promote a strong quality culture, deliver GDP training and identify opportunities to improve compliance and operational performance.

To be considered for this opportunity, you should possess:

• Registration as a Responsible Person with the Malta Medicines Authority and previous experience operating under a Wholesale Dealer Authorisation (WDA).
• Demonstrable experience within pharmaceutical GDP and Quality Assurance, ideally supporting Marketing Authorisation Holder (MAH) activities.
• A strong understanding of Quality Management Systems, supplier governance and pharmaceutical distribution compliance.
• Previous involvement in regulatory inspections, external audits and interactions with Competent Authorities.
• Excellent communication and stakeholder management skills, with the ability to influence quality standards across both internal teams and external partners.