Quality Control Manager

2 months ago

Sydney, Australia On Q Recruitment Full time

Our client is a newly established organisation looking to build a world-class team to deliver cutting-edge solutions to the biopharmaceutical industry. This newly created role is a unique opportunity to join a growing company at a pivotal stage and make a significant impact on their future success.

About the role:    
The QC Manager will be instrumental in shaping and leading the Quality Control function of our client 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 is a critical role in ensuring that all products meet stringent quality standards and that the company is inspection-ready as they scale.

Your key responsibilities will include, but will not be limited to:

  • Managing the day to day operations of the Quality Control laboratory including but not limited to:  ensuring all QC equipment is validated and safely operated; all physical QC assets are maintained, stored and organised to allow efficient and effective operation.
  • Leading, mentoring, and managing the QC team, fostering a culture of accuracy, accountability, and continuous improvement.
  • Ensuring that analytical methods are adequately developed, validated, transferred and maintained.
  • Developing, maintaining and communicating Lab Key Performance Metrics (KPIs).
  • Overseeing  the testing and release of raw materials, in-process samples, and final products, ensuring adherence to the highest quality standards.
  • Collaborating with cross-functional teams, including Manufacturing, QA, and Process Development, to optimise quality processes throughout the production lifecycle.
  • Ensuring the timely identification, reporting, and resolution of deviations, OOS (Out of Specification) results, and quality-related issues.
  • Driving continuous improvement initiatives to enhance QC processes.

To be considered for this role, you will have the following qualifications and skills:

  • Bachelor’s or Master’s degree in Biological Sciences, Biotechnology, or a related field.
  • At least 8 years of Quality Control experience. Experience working with biological product is a must have for this role. A strong expertise in viral vectors, gene therapy, or vaccine production will be 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.

For a confidential conversation about the role, please email  Grace Bitodi at gbitodi@onqrecruitment.com.au.

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