Quality Assurance Senior Manager

Clinigen is a leading global specialty pharmaceutical and services company dedicated to improving patient outcomes through the secure and timely delivery of vital medicines worldwide.

Requirements

• Provide strategic leadership and direction for all Quality Assurance activities within Clinigen to ensure compliance with GxP regulations and other relevant quality standards.
• Develop, implement, and maintain quality management systems that support the company’s operational and commercial objectives.
• Lead and mentor a team of quality professionals, promoting professional development and high performance.
• Ensure readiness for regulatory inspections and client audits, including managing audit responses and corrective action plans.
• Collaborate cross-functionally with departments such as Regulatory Affairs, Manufacturing, and Distribution to embed quality principles throughout the business.
• Monitor and report on quality metrics, driving continuous improvement initiatives and risk mitigation strategies.
• Ensure compliance with applicable legislation including the Misuse of Drugs Act, EU Falsified Medicines Directive, and other relevant regulations.

Benefits

• Competitive monthly salary
• Performance bonus
• Ongoing professional development opportunities