About the job
Clinigen Group plc is a global specialty pharmaceutical and services company dedicated to improving patient outcomes by delivering essential medicines safely and on schedule. With a workforce of over 1,100 employees, Clinigen operates in the UK, US, EU, JAPAC, and South Africa.
Role overview
The Senior Manager of Quality Assurance leads quality assurance functions across several divisions in Sydney, New South Wales. This senior leadership role ensures adherence to regulatory standards and internal policies. The position requires strong leadership skills, strategic planning, and a focus on building a culture committed to quality and continuous improvement.
Main responsibilities
- Set strategic direction and oversee all Quality Assurance activities, maintaining compliance with GxP and related quality standards.
- Develop, implement, and maintain quality management systems that align with Clinigen’s operational and commercial goals.
- Lead, mentor, and support the quality assurance team, encouraging professional growth and strong performance.
- Coordinate preparations for regulatory inspections and client audits, including managing audit responses and corrective actions.
- Work closely with Regulatory Affairs, Manufacturing, and Distribution teams to integrate quality principles throughout the organization.
- Track and report on quality metrics, driving initiatives for ongoing improvement and risk reduction.
- Ensure compliance with legislation such as the Misuse of Drugs Act, EU Falsified Medicines Directive, and other relevant regulations.

