QA Systems & Compliance Associate – External Quality

BioMarin Pharmaceutical Inc.; Cork; On-site; EUR 42,000 - 62,000; Full time

Job summary

BioMarin Pharmaceutical Inc. in Ireland is seeking an External QA Quality Associate on a 12 month contract within the Quality Systems & Compliance team. The role focuses on supporting the QMS, overseeing deviations, CAPAs and change controls, and ensuring regulatory alignment.

You will engage in metrics review, digital improvement initiatives, and cross‑functional governance, with training delivery and collaboration across GEO and external partners.

Qualifications

• Bachelor’s degree in science or engineering required.
• Minimum 1+ year biopharma QA/compliance experience.
• Strong data analysis, communication and collaboration skills.

Responsibilities

• Review Quality Systems metrics for GEO and drive timely closure of records.
• Support digital improvements for External Quality initiatives.
• Lead cross-functional meetings to close deviations, CAPAs and change controls.
• Develop and report metrics; help standardize across the organization.
• Coordinate monthly SQRT governance meetings for GEO.
• Deliver training on Quality Management Systems as needed.
• Collaborate with Global Quality Systems and cross-functional teams on QMS.
• Identify and implement continuous improvement in External Quality systems.
• Participate in change control for qualified systems (GEO).
• Assist in audits and inspections as required.
• Support global alignment projects with BioMarin sister sites.
• Support Self Inspection Programme for External Quality.
• Perform other duties as assigned.

Skills

Data analysis

Excel

Power BI

AI tools

Communication

Education

Bachelor’s Degree in science or engineering

Tools

Power BI

AI tools

Job description

BioMarin Pharmaceutical Inc. in Ireland is seeking an External QA Quality Associate on a 12 month contract within the Quality Systems & Compliance team. The role focuses on supporting the QMS, overseeing deviations, CAPAs and change controls, and ensuring regulatory alignment.

You will engage in metrics review, digital improvement initiatives, and cross‑functional governance, with training delivery and collaboration across GEO and external partners.