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.
Key Responsibilities:
* Manage the day-to-day operations of the Quality Management System (QMS), including document control, change control, deviations, CAPA, complaints, and vendor qualification activities.
* 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 in a scientific discipline or equivalent.
* 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.