QUALITY ASSURANCE MANAGER

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 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.

- 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