Quality Compliance Specialist

4 days ago

Dún Laoghaire, Dún Laoghaire-Rathdown, Ireland beBeeRegulatory Full time €85,000 - €110,000
">Senior Quality Assurance Professional

We are seeking a highly skilled and experienced Senior Quality Assurance Professional to join our team. This senior-level role is part of the broader Quality function, playing a vital part in ensuring quality and compliance across operations.

">About the Position

The Senior Quality Assurance Professional will serve as a Subject Matter Expert (SME) in assigned quality systems, driving improvements and ensuring compliance with regulatory standards. The ideal candidate will have strong knowledge of Deviation/CAPA, Change Control, QRM, and Documentation Management systems, as well as the ability to influence cross-functional teams.

">Key Responsibilities
  • Oversight and continuous improvement of key site quality systems, including Change Control, Deviation/CAPA, and Documentation Management.
  • Provide expert input and guidance during Change Control and Deviation Review Boards.
  • Management of Quality Risk Management (QRM) processes, including integration of QRM principles within quality frameworks.
  • Maintain and enhance the Quality Management Review process and ensure alignment with corporate policies.
  • Ownership of trending programs related to quality systems and the ability to interpret data to inform optimisation strategies.
  • Monitor regulatory updates and ensure that the site quality systems remain compliant and inspection-ready.
  • Drive sustained compliance initiatives, including self-inspections, internal audits, and continuous improvement activities.
  • Develop and manage Quality Agreements relevant to the specialist area.
">Qualifications and Experience
  • Degree in Science, Engineering, or related discipline.
  • 8+ years' experience in QA roles within the pharmaceutical or biotechnology industry.
">Preferred Qualifications
  • Strong written and verbal communication skills.
  • Experience with root cause analysis, investigations, and problem-solving.
  • Excellent understanding of regulatory expectations and inspection readiness.
  • Experience in aseptic operations, protein formulation, vial, and syringe filling is highly advantageous.
  • Proven ability to manage cross-functional collaboration and influence stakeholders.
">

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