We are seeking an experienced Quality Compliance Lead to oversee and maintain GMP compliance for on-site and contractor activities within a pharmaceutical environment based in Co.Westmeath. This role would be a great opportunity for a Quality Professional within Pharmaceuticals who is looking to move into a broad QMS and people management position. This is a permanent opportunity offering hybrid working.
Key Responsibilities:
* Manage the day-to-day operations of the Quality Management System (QMS), including:
o Document Control
o Change Control
o Deviations and CAPA
o Complaints and vendor qualification activities
o Internal and external audits
* Lead and mentor a team of quality compliance professionals.
* Maintain and report on quality metrics.
* Support regulatory inspections and ensure compliance with HPRA, EU/US regulations.
* Provide quality oversight for product launches in new markets.
* Drive continuous improvement initiatives across procedures, processes, and systems.
Requirements:
* Bachelor’s degree (or equivalent) in a scientific discipline.
* Minimum 5 years’ experience in a similar role within pharmaceutical manufacturing.
* Previous experience leading teams is highly desirable.
* Broad knowledge of QMS compliance and EU/US pharmaceutical regulations (HPRA, USP, ICH, EU GMPs, FDA etc.).
* Strong organizational and interpersonal skills, with the ability to manage multiple responsibilities.
For a confidential discussion about this opportunity please contact Ranait Coughlan
ranait.coughlan@collinsmcnicholas.ie
(090) 6450664 / (01) 66 200 88
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