Director, Global Quality Ops - Europe & International

Azurity Pharmaceuticals; Dublin; On-site; EUR 180,000 - 240,000; Full time

Job summary

Azurity Pharmaceuticals, a privately held specialty pharma company, seeks a Director of Quality Operations Europe & International to lead quality oversight for commercial products across Europe and international markets. The role acts as QP/RP for MIA and WDA, ensuring GMP/GDP compliance and reliable product supply.

You will oversee contract manufacturers, labs, warehouses, and distribution partners, manage deviations and CAPAs, and liaise with HPRA and regulatory authorities while driving

Qualifications

• Must have QP/RP on MIA/WDA licensed operations and Health Authority inspections.
• Degree in Pharmacy, Chemistry, Life Sciences, or related discipline.
• 15+ years of pharmaceutical quality experience within GMP/GDP-regulated environments.
• Strong knowledge of EU GMP, GDP, quality systems, and regulatory requirements.
• Proven leadership, stakeholder management, and external vendor oversight experience.

Responsibilities

• Provide quality leadership and oversight 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 approved Marketing Authorizations and regulatory requirements.
• Lead management of returns, product recalls, notification of quality defects, and Health Authority notifications.
• Maintain inspection readiness and lead interactions with HPRA and other regulatory authorities.
• Maintain quality agreements and support periodic vendor performance reviews.
• Conduct annual self-inspections and ensure effective implementation of corrective actions.
• Drive quality risk management, issue escalation, and compliance governance in alignment with global quality procedures.
• Partner with Regulatory Affairs, Supply Chain, Commercial, and Technical Operations to ensure uninterrupted product supply.

Skills

QP/RP experience

Quality leadership

Regulatory compliance

Stakeholder management

Vendor oversight

GMP/GDP knowledge

Education

Degree in Pharmacy, Chemistry, Life Sciences

Tools

Veeva Quality Vault

Job description

Azurity Pharmaceuticals, a privately held specialty pharma company, seeks a Director of Quality Operations Europe & International to lead quality oversight for commercial products across Europe and international markets. The role acts as QP/RP for MIA and WDA, ensuring GMP/GDP compliance and reliable product supply.

You will oversee contract manufacturers, labs, warehouses, and distribution partners, manage deviations and CAPAs, and liaise with HPRA and regulatory authorities while driving