Manager, Europe/International Quality Operations and EU QP

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.

Brief team/department description:

Azurity Pharmaceuticals Ireland Ltd. is seeking a Qualified Person (QP) to lead EU batch release activities and ensure full compliance with EU GMP and GDP regulations. In addition to core EU responsibilities, this role will support global quality operations including CMO oversight, deviation \& CAPA management, change control, audits, and technical batch release.

Principle Responsibilities:

EU QP

• Certify and release commercial and clinical batches in accordance with EU GMP (Directive 2001/83/EC and 2001/20/EC).


• Ensure product compliance with Marketing Authorizations and Manufacturing \& Import Authorization (MIA) requirements.


• Hoste regulatory inspections from HPRA, manage follow\-up actions, and liaise with EU authorities.


• Engage in EU Quality Management System: deviation \& CAPA handling, change control, product quality reviews, and risk assessments.


• Support review or/and conducting GMP/GDP audits of CMOs, 3PLs, and contract labs within the EU.


• Support continuous improvement and training of QA personnel related to EU compliance requirements.

• Provide QA oversight for CMOs based in EU/EEA/RoW, including deviation \& CAPA assessment, change control management.


• Conduct and/or review quality audits for facilities and service providers.


• Assess technical documentation for batch disposition (e.g. CoA/CoCs, artwork, deviation investigation reports, stability data) to support in\-market product release.


• Ensure quality processes align with international standards and local market requirements.


• Collaborate with Supply Chain, Regulatory, Technical Operations, for the supply of medicinal products to the various markets.

• Must meet the HPRA criteria to act as EU QP under EU legislation.


• Degree in pharmacy, chemistry, or biology.


• Minimum 8 years in pharmaceutical QA.


• Previous experience as a QP or Deputy QP.


• Experience with HPRA inspections is beneficial.

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