Cell Therapy Quality Assurance Director
1 dag geleden
We are Galapagos, a dynamic and growing Biotech company with offices across Europe and the US, headquartered in Mechelen, Belgium.
We're in the business of changing lives. In our quest to discover and develop life-improving medicines we go where no one has ever gone before. In every challenge we face, we see new opportunities. We pioneer for patients. We need thought leaders and rapid thinkers, entrepreneurs in spirit and status quo-fighters. Collaborative innovators and perseverant idealists. We need the best-in-class. In other words, we need you: The 'make-it-happener'.
As our Cell Therapy Quality Assurance Director, you will play a key role in shaping strategic directions in close collaboration with QC, Manufacturing, Supply Chain and other internal and external stakeholders as we are rapidly scaling up our activities in Europe and the US.
About the Role- You will be responsible for developing and implementing quality systems related to decentralized manufacturing ('point of care manufacturing')
- Ensure compliance with regulatory requirements, industry standards, and company policies across all stages of cell and gene therapy product development, manufacturing, and distribution.
- You will stay abreast of relevant regulatory guidelines and ensure adherence to applicable regulations, such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and Good Clinical Practices (GCP)
- Develop and implement effective oversight of quality control processes to ensure the accurate and reliable testing and release of cell and gene therapy products
- Define and maintain strong relationships with external testing laboratories and contract manufacturing organizations (CMOs)
- Lead the development and implementation of risk management strategies to identify, assess, and mitigate quality risks associated with cell and gene therapy products
We offer a competitive salary range of $120,000 - $180,000 per year, depending on experience, plus additional benefits including health insurance, retirement plan, and paid time off.
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