Senior Quality Assurance Lead

3 days ago

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

We are seeking a seasoned Senior Quality Assurance Lead to join our team at On Q Recruitment. This is an exceptional opportunity for a highly skilled professional to take on a pivotal role in shaping and leading our Quality Control function.

The ideal candidate will bring strong technical expertise in leading QC teams for biological products and will be a hands-on leader capable of establishing robust QC systems in compliance with GMP standards. This critical role is instrumental in ensuring that all products meet stringent quality standards and that the company is inspection-ready as we scale.

Key Responsibilities
  • Manage the day-to-day operations of the Quality Control laboratory, ensuring all QC equipment is validated and safely operated, and all physical QC assets are maintained, stored, and organised to allow efficient and effective operation.
  • Lead, mentor, and manage the QC team, fostering a culture of accuracy, accountability, and continuous improvement.
  • Ensure analytical methods are adequately developed, validated, transferred, and maintained.
  • Develop, maintain, and communicate Lab Key Performance Metrics (KPIs).
  • Oversee the testing and release of raw materials, in-process samples, and final products, ensuring adherence to the highest quality standards.
  • Collaborate with cross-functional teams, including Manufacturing, QA, and Process Development, to optimise quality processes throughout the production lifecycle.
  • Ensure timely identification, reporting, and resolution of deviations, OOS results, and quality-related issues.
  • Drive continuous improvement initiatives to enhance QC processes.
Requirements
  • Bachelor's or Master's degree in Biological Sciences, Biotechnology, or a related field.
  • No less than 8 years of Quality Control experience, with experience working with biological products being essential for this role. Strong expertise in viral vectors, gene therapy, or vaccine production is highly regarded.
  • In-depth knowledge of GMP regulations and global standards (FDA, EMA, etc.).
  • Demonstrated experience in leading a QC team.
  • Strong problem-solving and analytical skills, with attention to detail.
  • Excellent communication skills, with the ability to collaborate across departments and drive QC excellence.
  • Ability to thrive in a fast-paced, growing environment and manage multiple priorities effectively.
Salary Range

$140,000 - $180,000 per annum, depending on experience and qualifications.

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