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:
- Document Control
- Change Control
- Deviations and CAPA
- Complaints and vendor qualification activities
- 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