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Qa quality specialist

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BioMarin Pharmaceutical

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Location:
Ireland , Cork

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

This position reports to the Associate Director, External Quality, Quality Systems, & Compliance. This role has four areas of responsibility: Supporting the Quality Systems program within External Quality ensuring key Quality System elements such as Deviations, CAPA’s, and Change Controls are consistently administered and in compliance with relevant Regulatory Standards; Supporting Continuous Improvement Governance and project implementation; Ensuring inspection readiness of the External Quality team and external partners.

Job Responsibility:

  • Perform the Quality Systems Metric Review for External Quality and oversee relevant metrics and trending for each quality system to proactively drive on-time closure of Quality records
  • Responsible for managing routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control, with leadership endorsement
  • Responsible for development/reporting of metrics and supporting standardization of these across the Organization
  • Co-ordinate monthly governance site quality review team (SQRT) meeting for GEO / External Quality
  • Deliver training on Quality Management Systems, as required
  • Partner with the Global Quality Systems Management Team and other cross functional groups to ensure proper application of the QMS
  • Identify and implement continuous improvement initiatives to the External Quality systems
  • Assist as needed in audits and inspections
  • Participate in development and implementation of global alignment projects with BioMarin’s sister sites
  • Manage the Self Inspection Programme for External Quality
  • Other duties as assigned.

Requirements:

  • Bachelor’s Degree in science or engineering
  • Minimum 3+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting
  • Skilled in data analysis and excel
  • Strong communication and interpersonal skills – Oral, written and presentation skills
  • Works collaboratively with others to meet shared objectives.

Nice to have:

Power bi experience desirable.

Additional Information:

Job Posted:
December 26, 2025

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