QA Systems & Compliance Associate (12-Month Contract)

BioMarin Pharmaceutical Inc.; Cork; On-site; EUR 42,000 - 64,000; Full time

Job summary

BioMarin Pharmaceutical Inc. is seeking an External QA Quality Associate for a 12‑month contract in Ireland to support Quality Systems within External Quality (GEO). You will oversee deviations, CAPAs, and change controls, driving timely closure and data-driven improvements.

The role requires a degree in science or engineering and 1+ years in biopharma quality/compliance. Strong data skills, Excel, and teamwork are essential for cross-functional collaboration and audits.

Qualifications

• Bachelor’s Degree in science or engineering.
• Minimum 1+ years of biopharmaceutical experience in a Quality, Compliance, and/or Regulatory setting.
• Skilled in data analysis and Excel. Power BI and AI tool’s experience desirable.
• Strong communication and interpersonal skills – Oral, written and presentation skills.
• Works collaboratively with others to meet shared objectives.

Responsibilities

• Perform the Quality Systems Metric Review for GEO and oversee relevant metrics and trending for each quality system within GEO to proactively drive on-time closure of Quality records.
• Support development and implementation of digital improvement initiatives for External Quality.
• 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.
• Deliver training on Quality Management Systems within GEO, 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.
• Participate in the change control program for modifications to qualified systems (within GEO).
• Assist as needed in audits and inspections.
• Participate in development and implementation of 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

AI tools

Communication

Collaboration

Education

Bachelor’s degree in science or engineering

Tools

Power BI

AI tools

Job description

BioMarin Pharmaceutical Inc. is seeking an External QA Quality Associate for a 12‑month contract in Ireland to support Quality Systems within External Quality (GEO). You will oversee deviations, CAPAs, and change controls, driving timely closure and data-driven improvements.

The role requires a degree in science or engineering and 1+ years in biopharma quality/compliance. Strong data skills, Excel, and teamwork are essential for cross-functional collaboration and audits.