Manager, Quality Systems

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:

To support and maintain a robust, inspection-ready Quality System in alignment with global regulatory standards, ensuring operational excellence, data integrity, and continuous improvement in GxP environments. This role encompasses management of key quality processes including Change Control, Product Quality Reviews, and Risk Management.

Principle Responsibilities:

• Maintain an efficient, compliant, and inspection-ready Quality System aligned with applicable GxP regulations and industry best practices
• Oversee the end-to-end change control process, ensuring timely assessment, approval, and implementation in compliance with applicable regulations.
• Coordinate and ensure timely completion of PQRs for all marketed products, including data collection, trending, evaluation, and final review.
• Support the implementation and monitoring of quality metrics and KPIs to assess system performance and identify areas for improvement.
• Provide governance for quality risk management processes and ensure timely escalation of significant issues to senior management.
• Manage Quality Risk Escalation and Quality Council meetings
• Identify and drive continuous improvement initiatives in quality systems and processes.
• Regularly report quality system metrics, status of change controls, and PQRs to the Head of Quality Compliance. Prepare dashboards and presentations as needed.

Qualifications and Education Requirements

• Bachelor’s or Master’s degree in Life Sciences, Pharmacy, or a related discipline.
• Minimum 5 years of experience in pharmaceutical/biotech quality systems or quality assurance roles.
• Experience in PQR and change control management.
• Excellent communication, leadership, and problem-solving skills.
• Experience with quality audits and regulatory inspections is an advantage.

By applying for this role, you confirm that you are mentally and physically capable of fulfilling the job responsibilities detailed in the job description without any restrictions. If you have any concerns or even the slightest disability that may affect your ability to perform the job, please inform HR in advance.