Regulatory Quality Systems Lead - Vaccine & Biologics

Merck; Ireland; On-site; EUR 70,000 - 100,000; Full time

Job summary

Merck Ireland is seeking a Quality Systems and Compliance - Regulatory Compliance Specialist to ensure vaccine and biologics manufacturing adheres to cGMP and regulatory requirements. You will help maintain ALCOA data integrity, manage regulatory requests, and support audits while promoting a compliant culture on site.

The role reports to the Quality Systems and Compliance Associate Director and requires collaboration across departments to ensure timely regulatory deliverables and robust quality

Qualifications

• Experience in Regulatory Affairs, Quality Assurance, or Regulatory Compliance within GMP-regulated pharma/biologics manufacturing.
• Hands-on knowledge of CMC regulatory submissions and health authority Q&A cycles.
• Experience coordinating regulatory documentation across functions and sites.

Responsibilities

• Prepare GMP dossiers to support new submissions.
• Prepare ancillary documents for Module 1 of regulatory dossiers.
• Author/review responses to agency questions and renewals.
• Maintain site master file, GMP certificates, and HPRA notifications.
• Participate in audits/inspections and drive compliance improvements.
• Support regulatory compliance metrics and cross-functional collaboration.

Skills

Regulatory Affairs

Quality Assurance

Regulatory Compliance

CMC submissions

Technology transfer

Education

Bachelor's degree or higher in related science

Job description

Merck Ireland is seeking a Quality Systems and Compliance - Regulatory Compliance Specialist to ensure vaccine and biologics manufacturing adheres to cGMP and regulatory requirements. You will help maintain ALCOA data integrity, manage regulatory requests, and support audits while promoting a compliant culture on site.

The role reports to the Quality Systems and Compliance Associate Director and requires collaboration across departments to ensure timely regulatory deliverables and robust quality