Quality Manager / Responsible Person

About the Opportunity

An established international pharmaceutical company is seeking an experienced Quality Manager / Responsible Person to join its European Quality team. This is a fantastic opportunity to join a growing business operating across Europe, the Middle East and Africa, where you'll play a pivotal role in ensuring the highest standards of quality and compliance across an outsourced manufacturing and distribution network. This is a hands-on, operational quality role suited to someone who enjoys working closely with both internal stakeholders and external partners while remaining technically involved in day-to-day quality activities.

The Role

Reporting into the European Quality function, you will be responsible for providing quality oversight across the supply chain, ensuring products are manufactured, stored and distributed in accordance with GDP and GMP requirements. The successful candidate will also undertake Responsible Person (RP) responsibilities for Ireland and act as a key quality representative across a broad network of contract manufacturers, logistics providers and distribution partners. This is an individual contributor role with no direct reports.

Key Responsibilities

• Act as the Responsible Person (RP) for Ireland.
• Ensure compliance with GDP, GMP and applicable regulatory requirements.
• Provide quality oversight across external manufacturers, warehouses and third-party logistics providers.
• Maintain and continuously improve the Quality Management System (QMS).
• Manage deviations, CAPAs, change controls and quality investigations.
• Review and approve quality documentation.
• Support internal and external audits, regulatory inspections and supplier qualification activities.
• Manage product complaints and quality events.
• Build strong relationships with Regulatory Affairs, Supply Chain, Commercial, Medical Affairs and Technical Operations.
• Drive continuous improvement initiatives across Quality Operations.

About You

You will be an experienced Quality professional who enjoys working in a collaborative environment where quality decisions have a direct impact on the business.

Essential Requirements

• Degree in Life Sciences, Pharmacy or a related discipline.
• Significant Quality experience within the pharmaceutical industry.
• Strong working knowledge of GMP and GDP.
• Experience within Quality Operations and Quality Management Systems.
• Demonstrated experience managing:
  • Deviations
  • CAPAs
  • Change Controls
  • Product Complaints
  • Quality Investigations
  • Internal and External Audits
• Experience working with contract manufacturers (CMOs), distributors and third-party logistics providers.
• Excellent stakeholder management and communication skills.

Highly Desirable

• Current or previous Responsible Person (RP) experience.
• Experience operating under an Irish or EU Wholesale Distribution Authorisation (WDA).
• Experience supporting Health Authority inspections.
• Experience working within outsourced manufacturing and distribution models.

What We're Looking For

We're looking for someone who is:

• Technically strong and confident making quality decisions.
• Comfortable working independently within a lean, collaborative team.
• Hands-on and solutions focused.
• Organised with excellent attention to detail.
• Able to influence stakeholders across multiple business functions.
• Passionate about maintaining high quality standards while supporting business growth.