Quality Director

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Lead Quality Assurance Consultant - United Kingdom & Ireland

Blackfield are partnered a leading organisation in the pharmaceutical and healthcare services sector, is seeking a Quality Director – Responsible Person based in Dublin.

The Quality Director will hold primary responsibility for the development, implementation, and ongoing maintenance of the Quality Management System, ensuring full compliance with Good Distribution Practice, Good Manufacturing Practice, and applicable regulatory requirements. This role is pivotal in maintaining the organisation's Wholesale Distribution Authorisation and ensuring adherence to obligations as a Marketing Authorisation Holder.

The Quality Director will also oversee Pharmacovigilance activities, Regulatory Affairs, and Advertising compliance, ensuring robust systems and processes are in place to manage safety data, regulatory submissions, and promotional material reviews. The role involves cross-functional collaboration with internal stakeholders and external partners, ensuring end-to-end compliance across all product-related activities.

Key Responsibilities

• Responsible Person & Regulatory Compliance Oversight: Serve as the designated Responsible Person, ensuring the organisation meets all obligations under its Wholesale Distribution Authorisation, with full compliance to Good Distribution Practice, Good Manufacturing Practice, Medical Device regulations, and Marketing Authorisation Holder responsibilities.
• Quality Management System Leadership: Lead the development, implementation, and continuous improvement of the Quality Management System, including quality agreements, audits, deviation management, corrective and preventive actions, change control, and inspection readiness.
• Pharmacovigilance & Regulatory Affairs Management: Oversee Pharmacovigilance operations ensuring compliance with global safety reporting obligations; manage Regulatory Affairs activities including product licensing, variations, labelling, submissions, and promotional compliance aligned with regulatory expectations.
• Cross-functional Collaboration & Team Leadership: Lead and develop the Quality team, foster collaboration with Supply Chain, Commercial, and Regulatory Affairs functions, manage external partners/vendors, and act as subject matter expert on Exempt Medicinal Products, driving process improvements and operational excellence.

The successful candidate will have three to five years of experience in a regulated pharmaceutical environment, with proven expertise in Pharmacovigilance operations, Regulatory Affairs, and distribution compliance. Prior experience as a Responsible Person under a Wholesale Distribution Authorisation is essential. A strong understanding of Good Distribution Practice and Marketing Authorisation Holder responsibilities is required, along with experience managing safety data, regulatory submissions, and promotional compliance. A Bachelor's degree in a scientific or healthcare discipline is preferred.

If you are interested in this opportunity, please send your up-to-date CV to Oliver@BlackfieldAssociates.com or call Oliver on 02392 314 792.

Seniority level

• Seniority levelDirector

Employment type

• Employment typeFull-time

Job function

• Job functionQuality Assurance
• IndustriesBiotechnology Research, Pharmaceutical Manufacturing, and Transportation, Logistics, Supply Chain and Storage

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