Manager, Quality Systems

Job Description

Azurity Pharmaceuticals is seeking a Manager, Quality Systems to be based in Hyderabad. The Manager will 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.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.

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.