Quality Compliance Lead
We are seeking an experienced Quality Compliance Lead to oversee and maintain GMP compliance for on-site and contractor activities within a pharmaceutical environment.
This is a broad QMS and people management position, ideal for a Quality Professional within Pharmaceuticals looking to move into a leadership role.
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 and 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)
* Strong organizational and interpersonal skills, with the ability to manage multiple responsibilities