Summary of Position

• Ensure Curium's compliance with the requirements of Good Manufacturing Practice
• Take ownership, maintain and continuously improve the site Quality Management System (QMS), ensuring alignment with current regulations, guidelines and industry standards along with the site QPs

Note: The vacancy is a maternity cover (fixed-term contract).

Essential Functions

• Ensure ongoing compliance with EU GMP Annex 1, Annex 3, Annex 11, Annex 16, HPRA, EMA regulations and Curium requirements.
• Take ownership and maintain various aspects of the Quality Management System for PET radiopharmaceutical production.
• Review, approve and manage deviations, CAPAs, Risk Assessments, root cause investigations, Change Controls, OOS/OOT, Complaints, recalls, withdrawals, Quality Agreements and Supplier Agreements.
• Provide quality oversight for new product and technology launches and validation activities.
• Initiate and champion continuous process improvements.
• Support HPRA inspections, second-party and first-party audits.
• Develop and deliver SOPs, Training programs and assess training effectiveness.
• Track, trend and report Quality metrics.

Requirements

• Minimum Bachelor’s degree in Pharmacy, Life Sciences, or a related discipline.
• Educational qualifications meeting EU QP eligibility requirements as defined in Directives 2001/83/EC and applicable national legislation.
• 3+ years of Quality experience in a pharmaceutical manufacturing GMP environment.
• Strong working knowledge of EU GMP Annex 1, Annex 3, Annex 16 and HPRA expectations.
• Experience managing quality systems, audits, deviations, CAPAs, and change control.
• Proven ability to work cross‑functionally and manage multiple priorities.
• Batch release/disposition experience preferred.
• Good communication and time management skills.

This position is fully site-based and requires on-site presence five days per week.