Biopharmaceutical Quality Assurance Lead

3 weeks ago

Sydney, New South Wales, Australia On Q Recruitment Full time

Our client is a pioneering biotech firm seeking a seasoned expert to spearhead their Quality Control function. This critical role will play a pivotal part in shaping the company's quality assurance strategies and ensuring compliance with GMP standards.

About the Role

The Quality Assurance Lead will be responsible for overseeing the day-to-day operations of the Quality Control laboratory, including equipment validation, asset maintenance, and team management. Key responsibilities include:

  • Lab Operations Management: Ensure all QC equipment is validated and safely operated, and physical QC assets are maintained, stored, and organised to facilitate efficient operation.
  • Team Leadership: Lead, mentor, and manage the QC team, fostering a culture of accuracy, accountability, and continuous improvement.
  • Method Development and Validation: Develop, validate, transfer, and maintain analytical methods to ensure compliance with regulatory requirements.
  • KPI Development and Communication: Develop, maintain, and communicate lab key performance metrics to stakeholders.
  • Raw Material, In-Process Sample, and Final Product Testing and Release: Oversee testing and release activities, ensuring adherence to the highest quality standards.
  • Cross-Functional Collaboration: Collaborate with manufacturing, QA, and process development teams to optimise quality processes throughout the production lifecycle.
  • Deviation, OOS, and Quality Issue Resolution: Timely identify, report, and resolve deviations, OOS results, and quality-related issues.
  • QC Process Improvement: Drive continuous improvement initiatives to enhance QC processes.

To excel in this role, you'll need:

  • Bachelor's or Master's degree in Biological Sciences, Biotechnology, or a related field.
  • At least 8 years of Quality Control experience, with expertise in biological product development.
  • 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 ability to collaborate across departments.

For this challenging and rewarding opportunity, we estimate an annual salary of $120,000 - $150,000, commensurate with experience.

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