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Senior Manager of Quality Assurance

Clinigen Group plcSydney, New South Wales, Australia
On-site Full-time

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Experience Level

Senior Level Manager

Qualifications

Requirements:Bachelor’s degree in Pharmacy, Life Sciences, or a related discipline; advanced qualifications or certifications in Quality Assurance are strongly preferred. A minimum of 8 years of extensive experience in Quality Assurance within the pharmaceutical sector, including a background in senior management. Comprehensive understanding of global pharmaceutical regulations including GxP, GDP, EU legislation (EudraLex), and the Human Medicines Regulations. Demonstrated ability to lead and cultivate high-performing teams within a regulated environment. Strong analytical, problem-solving, and decision-making skills with a strategic outlook. Outstanding communication and interpersonal abilities, capable of influencing stakeholders at all levels. Proven experience in successfully managing regulatory inspections and client audits. A clear commitment to continuous improvement and enhancement of quality culture.

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.

About Clinigen Group plc

Clinigen is a premier global specialty pharmaceutical and services provider, dedicated to ensuring better patient outcomes through the timely and secure delivery of critical medicines around the world. Our ongoing commitment to innovation and excellence has made us a leader in the pharmaceutical sector.

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