Biopharmaceutical Quality Control Lead
3 weeks ago
At On Q Recruitment, we are seeking a seasoned Quality Control Manager to join our client's growing team in the biopharmaceutical industry.
About the Role:
The QC Manager will play a pivotal role in shaping and leading the Quality Control function, ensuring all products meet stringent quality standards and the company is inspection-ready as they scale. This is a unique opportunity to join a growing company at a critical stage and make a significant impact on their future success.
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.
- 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.
- 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 the 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.
- At least 8 years of Quality Control experience, with a strong expertise in viral vectors, gene therapy, or vaccine production.
- 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.
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