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 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 assessment, change control, CAPA management, 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.
- Act as Responsible Person (RP) under the Wholesale Distribution License, ensuring compliance with EU GDP (2013/C 343/01).
- Host regulatory inspections from HPRA, manage follow-up actions, and liaise with EU authorities.
- Oversee EU Quality Management System: deviation handling, CAPAs, change control, product quality reviews, and risk assessments.
- Conduct and support GMP/GDP audits of CMOs, 3PLs, and contract labs within the EU.
- Drive continuous improvement and ensure training of QA personnel related to EU compliance requirements.
Quality Operations
- Provide QA oversight for CMOs based in EU/EEA/RoW, including deviation assessment, change control, and CAPA evaluation.
- Conduct and/or review quality audits for facilities and service providers.
- Assess technical documentation for batch disposition (e.g., CoAs, 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.
Qualifications and Education Requirements
- Advanced degree in pharmacy, chemistry, or biology.
- Minimum 10 years in pharmaceutical QA.
- Previous experience as a QP and experience with HPRA inspections is required.
- Must meet the HPRA criteria to act as EU QP under EU legislation.
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