QA Quality Specialist

QA Quality Specialist

BioMarin

Cork, Ireland

QA Systems & Compliance

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.

Key Responsibilities for this Role as follows:

• 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.

The ideal candidate will have the following experience/skills:

• 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. Power bi experience desirable.
• Strong communication and interpersonal skills – Oral, written and presentation skills.
• Works collaboratively with others to meet shared objectives.