Manager/Sr. Manager, Europe/International Quality Operations and EU QP

Overview

Role involves leading EU batch release activities and ensuring compliance with EU GMP and GDP regulations.

Ideal candidate should have 10+ years in pharmaceutical QA and experience as a QP.

Locations

• Ireland, Leinster, Dublin

Requirements

• Advanced degree in pharmacy, chemistry, or biology
• Minimum 10 years in pharmaceutical QA
• Previous experience as a QP required
• Experience with HPRA inspections required
• Must meet HPRA criteria to act as EU QP

Responsibilities

• Certify and release batches per EU GMP
• Ensure compliance with Marketing Authorizations
• Host regulatory inspections
• Oversee EU Quality Management System
• Conduct GMP/GDP audits
• Provide QA oversight for CMOs
• Assess technical documentation for batch disposition
• Collaborate with Supply Chain and Regulatory