EU & International Quality Operations Director

Azurity Pharmaceuticals - Ireland; Dublin; Hybrid; EUR 150,000 - 190,000; Full time

Job summary

Azurity Pharmaceuticals - Ireland is seeking a Director of Quality Operations Europe & International to provide quality oversight for commercial products in Europe and international markets. The role acts as Qualified Person (QP) and Responsible Person (RP) for MIA and WDA, ensuring GMP/GDP compliance and reliable product supply.

The ideal candidate has 15+ years in pharmaceutical quality within GMP/GDP environments, with strong EU regulatory knowledge and proven leadership in vendor oversight.

Qualifications

• QP/RP on MIA/WDA licensed operations and HPRA inspections required.
• Degree in Pharmacy, Chemistry, Life Sciences, or related discipline.
• 15+ years of pharmaceutical quality experience within GMP/GDP environments.
• Strong knowledge of EU GMP, GDP, quality systems and regulatory requirements.

Responsibilities

• Provide quality leadership for MIA and WDA licensed activities in Ireland.
• Qualify and oversee contract manufacturers, testing laboratories, warehouses, transporters and distribution partners.
• Manage and ensure timely closure of deviations, OOS investigations, CAPAs, change controls, and product quality events.
• Oversee in-market batch release, product distribution, and supply chain quality activities.
• Ensure products are manufactured and tested in accordance with Marketing Authorizations and regulatory requirements.
• Lead management of returns, product recalls, and Health Authority notifications.
• Maintain inspection readiness and lead interactions with HPRA and other regulators.
• Maintain quality agreements and support vendor performance reviews.
• Conduct annual self-inspections and ensure corrective actions are implemented.
• Drive quality risk management, escalation, and governance in line with global procedures.
• Partner with Regulatory Affairs, Supply Chain, Commercial, and Technical Operations to ensure uninterrupted product supply.

Skills

QP/RP experience

MIA/WDA licensed operations

Health Authority inspections

Education

Degree in Pharmacy, Chemistry, Life Sciences

Tools

Veeva Quality Vault

Job description

Azurity Pharmaceuticals - Ireland is seeking a Director of Quality Operations Europe & International to provide quality oversight for commercial products in Europe and international markets. The role acts as Qualified Person (QP) and Responsible Person (RP) for MIA and WDA, ensuring GMP/GDP compliance and reliable product supply.

The ideal candidate has 15+ years in pharmaceutical quality within GMP/GDP environments, with strong EU regulatory knowledge and proven leadership in vendor oversight.