Job Description

Job Title: Quality Manager / Responsible Person (RP)
Location: Dublin
Reports To: Director of Quality

About the Company:

Our client is a global leader in clinical trials, dedicated to delivering high-quality solutions that meet regulatory and customer requirements. With operations worldwide, the company is committed to innovation, compliance, and excellence in the healthcare industry.

Role Overview:

The Quality Manager / Responsible Person (RP) will oversee the Quality Management System (QMS) to ensure compliance with regulatory requirements and industry standards for clinical trials, packaging, and labelling. Reporting directly to the Director of Quality, the role will involve leading the Quality team, managing daily quality operations, and ensuring Good Distribution Practice (GDP) compliance. The successful candidate will play a key role in maintaining the company’s high standards of quality, safety, and regulatory adherence.

Key Responsibilities:

• Act as the Responsible Person (RP), ensuring compliance with Good Distribution Practice (GDP) and other regulatory requirements.

• Lead, mentor, and develop the Quality team, overseeing their performance and professional growth.

• Manage and maintain the Quality Management System (QMS), ensuring compliance with EU and global regulatory standards.

• Oversee the packaging and labelling processes to ensure quality assurance and compliance.

• Ensure the company meets all regulatory licensing and certification requirements.

• Conduct internal audits, supplier audits, and manage external regulatory inspections.

• Develop and implement quality policies, procedures, and continuous improvement initiatives.

• Handle deviations, CAPAs, change controls, and other quality-related activities.

• Provide training and guidance to staff on GDP, regulatory updates, and quality best practices.

• Ensure proper complaint handling, recall procedures, and product release processes.

• Collaborate with cross-functional teams to drive operational excellence and compliance.

Requirements:

• Bachelor’s degree in Pharmaceutical Sciences, Life Sciences, Quality Management, or a related field.

• Minimum 5-7 years of experience in a quality management role within clinical trials, pharmaceuticals, packaging, or labelling.

• Proven experience as a Responsible Person (RP) under EU GDP requirements.

• Strong knowledge of GDP, GMP, GCP, and regulatory requirements for clinical trial supply chain operations.

• Experience leading and developing a high-performing team.

• Excellent problem-solving, communication, and leadership skills.

• Ability to manage multiple priorities in a fast-paced global environment.

• Strong attention to detail and a proactive approach to quality management.

What We Offer:

• Competitive salary and benefits package.

• Hybrid working model (Dublin-based).

• Career growth opportunities within a global organization.

• A collaborative and innovative work environment.