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.
The Director of Quality Compliance is responsible for ensuring the organization maintains an inspection-ready,compliant, and efficient Quality System that supports all GxP-related activities. This role oversees the electronicQuality Management System (eQMS), documentation management, data integrity, and the overall complianceinfrastructure. The individual will provide strategic leadership and operational oversight for quality systems, riskmanagement, training, and product complaint processes, ensuring adherence to global regulatoryrequirements, including 21 CFR Part 11 and EU Annex 11.
* Maintain a robust and inspection-ready Quality Management System (QMS).
* Oversee the validation, integrity, and ongoing compliance of electronic quality systems.
* Ensure procedures are appropriately authored, reviewed, approved, and updated.
* Manage the Documentation Management System and ensure all controlled documents meetregulatory standards.
* Maintain compliant training records and quality documentation in alignment with regulatoryexpectations.
* Lead the development and implementation of a GxP training program for relevant personnel.
* Support the development and tracking of quality metrics and key performance indicators (KPIs).
* Provide governance and facilitate Quality Risk Management processes, including timely escalation tosenior leadership.
* Lead continuous improvement initiatives for quality systems and processes.
* Oversee Change Control processes to ensure systematic and compliant change implementation.
* Manage the Product Quality Review (PQR) and Product Complaint programs, including investigations and Corrective and Preventive Actions (CAPAs).
* Oversee the Computer System Validation (CSV) program ensuring compliance with 21 CFR Part 11 and EU Annex 11.
* Serve as a primary quality compliance liaison with cross-functional departments, including Medical Affairs, Regulatory Affairs, and IT.
Qualifications and Education Requirements
* Bachelor’s or Master’s degree in Life Sciences, Pharmacy, Engineering, or a related field.
* Minimum of 10 years of experience in quality assurance, with at least 5 years in a leadership role within a GxP-regulated environment.
* In-depth knowledge of global regulatory standards (FDA, EMA, ICH, etc.) for quality systems.
* Strong expertise in risk management, product complaints, change control, and CSV.
* Proven ability to communicate complex compliance topics clearly to stakeholders at all levels.
* Excellent leadership, project management, and problem-solving skills.
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