Spclst, Quality Systems & Compliance

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

A fantastic and hugely exciting opportunity has arisen for a Quality Systems and compliance - Regulatory Compliance Specialist . Reporting to the Quality Systems and Compliance Associate Director, this role plays a key part in Regulatory Compliance at site. The role is responsible for helping ensure that vaccine and biologics manufacturing processes comply with cGMP and associated regulatory requirements, and that objectives are achieved consistently with our Company requirements for compliance, safety, and reliable supply to customers.

Bring energy, knowledge, innovation to carry out the following:

• Comply with and execute CGMP/GDP in the performance of day-to-day business activities.
• Ensure data integrity principles: Attributable, Legible, Contemporaneous, Original, and Accurate (ALCOA) are adhered to for records and data in day-to-day business activities.
• Work collaboratively to drive a safe and compliant culture on site.
• Management of regulatory requests that come to site including:
  • Preparation of GMP dossiers to support new submissions
  • Preparation of ancillary documents required to support module 1 of the regulatory dossiers in applicable markets
  • Author/review all related responses to agency questions
  • Preparation of documentation required to support product renewals, re-registrations and tender bids.
• Maintenance of Japanese site accreditation
• Maintenance of site GMP certificates and IMP/Commercial license
• Management of HPRA notifications for new product
• Management of the site master file
• Quality review of new product dossiers as part of BLA/MAA authoring
• Quality review of post approval change submissions
• Review of applicable change controls to determine impact to local documentation/regulatory requirements.
• Work collaboratively with site and above site teams to resolve regulatory compliance issues
• Participate in relevant product team meetings
• Participate in NPI tech transfer workshops to identify regulatory compliance deliverables
• Support regulatory compliance metrics and reporting
• Ensure and promote that adequate processes and procedures are in place and followed for all Quality activities.
• Liaise with the Quality/Business Area Specialists/QP/QA Lead as well as Quality Associate Specialist/Specialists to resolve quality related queries where required.
• Develop and maintain effective cross-functional relationships with other depts and support functions to ensure that the process for the manufacturing, testing and release of vaccine and biologic products are in compliance with cGMP and the associated regulatory requirements.
• Participate in internal and external audits and inspections, ensuring department compliance/readiness, taking the role of auditee for assigned areas of responsibility.
• Identify, influence and support compliance initiatives to improve compliance status and overall operational efficiency for batch release at the site.
• Execute/Review/Approve/Support deviation/CAPA activities, change controls, complaints, data integrity, quality agreements, Supplier/Material Qualification, cleaning verification/validation, Quality Risk Management processes and other documentation including generation, investigation, documentation, implementation, verification closure, effectiveness and trending where required for the Quality Department and supporting functions.
• Ensure and promote compliance to regulatory requirements.

What skills you will need:

• In order to excel in this role, you will more than likely have:
• Bachelor's degree or higher preferred, ideally in a related science discipline.
• Typically 5+ years' experience in Regulatory Affairs, Quality Assurance, and/or Regulatory Compliance within a GMP-regulated pharmaceutical or biologics manufacturing environment is preferred.
• Demonstrated track record in CMC regulatory submissions, dossier preparation, and management of complex health authority question-and-answer cycles, including compilation and review of large volumes of supporting documentation.
• Hands-on experience supporting technology transfer and new product introduction activities at a manufacturing site level, including coordination of regulatory documentation across functions.
• Demonstrated experience managing licensing activities: Site Master File updates, MIA/IMP license maintenance, HPRA notifications, and market-specific accreditation submissions.
• Experience designing and implementing regulatory tracking and knowledge-management systems that improve team performance, visibility, and business continuity.
• Ability to manage high volumes of concurrent regulatory activities - ancillary document requests, RTQs, change controls, SMF updates - to demanding timelines without compromising quality.
• In-depth knowledge of global regulatory frameworks: EMA, FDA, ICH guidelines, and Irish national requirements (HPRA).
• Strong