Director, Quality Operations Europe & International

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company that focuses on innovative products that meet the needs of underserved patients. As an industry leader in providing unique, accessible, and high-quality medications, Azurity leverages its integrated capabilities and vast partner network to continually its broad commercial product portfolio and robust late-stage pipeline. The company's patient-centric products span the cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, and have benefited millions of patients. For more information, visit www.azurity.com.

About the Role

The Director, Quality Operations Europe & International is responsible for quality oversight of commercial products across Europe and International markets and serves as Qualified Person (QP) and Responsible Person (RP) for the site Manufacturing & Importation Authorisation (MIA) and Wholesale Distribution Authorisation (WDA). The role ensures compliance with GMP, GDP, and Marketing Authorization requirements while supporting reliable product supply and business growth.

Key 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.

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.

Required Skills and Experience

Previous experience as QP/RP on MIA/WDA licensed operations and Health Authority inspections is required.

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.

Preferred Qualifications

Working knowledge of Veeva Quality Vault

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