About us and the role:
Icosagen Cell Factory is an Estonian biotechnology company striving to become a regional leader in the development and manufacturing of biologic drugs. As we expand our operations in Estonia, we are looking for a dedicated and experienced pharmaceutical/biotechnology industry Quality Assurance Manager to establish and manage a robust quality system for our chimeric antigen receptor CAR T cell program.

TO APPLY, please submit your letter of motivation along with your resume to personal@icosagen.com or through our website or CV Keskus.

Role responsibilities include but are not limited to:

• Develop, implement, and maintain a Quality Management System (QMS)
• Create and document key quality procedures
• Review and approve procedures
• Manage quality-related documentation
• Ensure GMP compliance
• Review and approve qualification protocols
• Implement and manage environmental monitoring
• Manage quality processes
• Conduct self-inspections
• Prepare for regulatory inspections

Required and preferred qualifications, desired qualities:

• Bachelor’s degree in Life Sciences, Pharmacy, Biotechnology, or a related field; advanced degree preferred.
• Minimum of 2 years of experience in quality assurance within the medical sector,
  pharmaceutical or biotechnology industry. Food industry can be considered.
• Strong knowledge of cell biology, cell culture and analytical techniques for immune cell analysis on the cellular and molecular level.
• Knowledge of GMP regulations and international standards (EMA, FDA) related to drug manufacturing preferred.
• Proven experience in establishing and implementing pharmaceutical quality systems.
• Strong problem-solving, communication and interpersonal skills with the ability to work collaboratively in a fast-paced, dynamic environment. Attention to detail.
• Being a self-starter and a team player.
• Fluency in written and oral English, knowledge of Estonian is a plus.

Our offer to you:

• Full time fixed-term employment contract in a leading, rapidly developing
  international biotech company
• An opportunity to make an impact in drug development
• Inspiring colleagues and supportive environment for professional
  development.
• Team-building events and activities.
• Company benefits package and team events.
• Work location in Tartu, Estonia.

To apply, please submit your letter of motivation along with your resume to personal@icosagen.com