Quality Systems Manager

1 month ago

Sydney, New South Wales, Australia On Q Recruitment Full time
About the Role

The Quality Systems Manager will be responsible for establishing, maintaining, and continuously improving the Quality Management System (QMS) to ensure compliance with regulatory standards (GMP, FDA, EMA). This critical role requires a hands-on leader who can develop robust quality systems that support efficient manufacturing processes and ensure inspection-readiness.

Key Responsibilities
  • Develop and implement the company's electronic Quality Management System (QMS) to ensure compliance with GMP and global regulatory standards.
  • Oversee document control, change management, and training programs related to the QMS.
  • Collaborate with cross-functional teams, including Manufacturing, QC, and QA, to drive process optimisation and adherence to quality standards.
  • Ensure the timely identification, reporting, and resolution of quality issues, including deviations, CAPAs, and risk assessments.
  • Lead internal audits, ensuring the organisation is always inspection-ready.
  • Drive continuous improvement initiatives to enhance quality systems and processes.
  • Provide leadership and training to the quality systems team, fostering a culture of accountability, accuracy, and continuous improvement.
Requirements
  • Bachelor's or Master's degree in Biological Sciences, Biotechnology, or a related field.
  • Minimum 8 years of experience in quality systems management within the pharmaceutical or biopharmaceutical industry.
  • In-depth knowledge of GMP regulations and global standards (FDA, EMA).
  • Proven experience in leading quality system initiatives. Experience developing and implementing new QMS from scratch will be highly regarded.
  • Strong problem-solving and analytical skills, with the ability to manage multiple projects in a fast-paced environment.
  • Excellent communication and leadership skills to work effectively across teams and drive quality excellence.

This is a unique opportunity to join a growing company at a pivotal stage and make a significant impact on their quality operations and future success.

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