QA Systems & Compliance Analyst

BioMarin Pharmaceutical Inc.; Cork; On-site; EUR 45,000 - 60,000; Full time

Job summary

BioMarin Pharmaceutical Inc. seeks an External QA Quality Associate to support the Quality Systems program within External Quality, ensuring deviations, CAPAs and change controls are administered in compliance with regulatory standards.

The role reports to the Associate Director, External Quality, Quality Systems & Compliance and will drive digital improvement initiatives, governance, metrics and audits across GEO in Ireland. 12-month contract in Cork.

Qualifications

• Bachelor's Degree in science or engineering required.
• Minimum 1+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting.
• Strong data analysis and Excel skills; Power BI and AI tools desirable.

Responsibilities

• Perform Quality Systems Metric Review for GEO and oversee metrics and trending to drive timely closure of Quality records.
• Support development and implementation of digital improvement initiatives for External Quality.
• Manage routine cross-functional meetings to ensure timely closure of Deviations, CAPAs and Change Control with leadership endorsement.
• Develop/report metrics and support standardization across the Organization.
• Coordinate monthly governance site quality review team (SQRT) meetings for GEO.
• Deliver training on Quality Management Systems within GEO as required.
• Collaborate with Global Quality Systems Management Team and cross-functional groups to ensure proper application of the QMS.
• Identify and implement continuous improvement initiatives to External Quality systems.
• Participate in change control program for modifications to qualified systems (within GEO).
• Assist in audits and inspections as needed.
• Participate in global alignment projects with BioMarin's sister sites.
• Support the Self Inspection Programme for External Quality.
• Other duties as assigned.

Skills

Data analysis

Excel

Power BI

Oral and written communication

Interpersonal skills

Education

Bachelor's Degree in science or engineering

Tools

Power BI

AI tools

Job description

BioMarin Pharmaceutical Inc. seeks an External QA Quality Associate to support the Quality Systems program within External Quality, ensuring deviations, CAPAs and change controls are administered in compliance with regulatory standards.

The role reports to the Associate Director, External Quality, Quality Systems & Compliance and will drive digital improvement initiatives, governance, metrics and audits across GEO in Ireland. 12-month contract in Cork.