Senior Specialist, 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 expand 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.

Azurity Pharmaceuticals is proud to be an inclusive workplace and an Equal Opportunity Employer. Azurity's success is attributable to our incredibly talented, dedicated team that focuses on benefiting the lives of patients by bringing the best science and commitment to quality into everything that we do. We seek highly motivated individuals with the dedication, integrity, and creative spirit needed to thrive in our organization.

About the Role

The Senior Specialist, Quality Operations Europe & International Quality Operations supports the Director, Quality Operations Europe & International in maintaining GMP and GDP compliance across Europe and International markets. The role provides operational oversight of quality systems, commercial product quality activities, external vendors, and licensed activities associated with the site Manufacturing & Importation Authorisation (MIA) and Wholesale Distribution Authorisation (WDA).

Key Responsibilities

• Support quality oversight of MIA and WDA licensed activities in Ireland.

• Coordinate qualification, approval, and ongoing monitoring of contract manufacturers, testing laboratories, warehouses, transporters and distribution partners.

• Manage quality events including deviations, OOS investigations, CAPAs, change controls, complaints

• Manage Product Quality Reviews (PQR)and quality risk assessments. 

• Ensure timely investigation, documentation, and closure of quality records in accordance with company procedures.

• Support batch release, distribution, and market supply activities by ensuring required quality documentation is reviewed and maintained.

• Verify compliance of manufactured products with approved Marketing Authorizations, GMP, GDP, and company quality standards.

 • Verify compliance of suppliers and customers (bona fide checks) for the authorized activities.

• Support management of product returns, quality defect notifications, product recalls, and Health Authority reporting requirements.

• Participate in vendor audits, self-inspections, and compliance assessments and track completion of resulting CAPAs.

 • Monitor quality metrics and identify compliance risks, trends, and opportunities for continuous improvement.

• Escalate quality and compliance issues through established governance processes.

Required Skills and Experience 

• Degree in Pharmacy, Chemistry, Life Sciences, or a related scientific discipline.

• 5+ years of pharmaceutical quality experience in GMP and/or GDP regulated environments. 

• Experience managing quality systems such as deviations, CAPAs, change controls, complaints, and supplier quality activities.

• Working knowledge of EU GMP, GDP, and pharmaceutical regulatory requirements.

• Experience supporting contract manufacturers, testing laboratories, transporters and distribution partners. 

• Strong organizational, analytical, and problem-solving skills.

• Strong written and verbal communication skills.

Preferred Qualifications

 • Working knowledge of Veeva Quality Vault

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