Overview
QA/QC Specialist (ATMP Manufacturing) Jobs in Ukraine at Centre of Science of Institute of Cell Therapy
Title: QA/QC Specialist (ATMP Manufacturing)
Company: Centre of Science of Institute of Cell Therapy
Location: Ukraine
About Us
We are the Institute of Cell Therapy (ICT), a Ukrainian company operating in the field of medical services, cell technologies, laboratory diagnostics, cryopreservation and related biotech/R&D activities. We are currently developing an advanced therapy medicinal product (ATMP) based on mesenchymal stem cells (MSCs) for the treatment of osteoarthritis, targeting EU market registration.
More information about our company is available on our website: https://instituteofcelltherapy.com/en/
Role Summary
We are looking for a QA/QC Specialist on the Sponsor side, for overseeing the GMP manufacturing of our MSC-based product at a contract manufacturer (CDMO).
You will build and maintain the quality system on the Client side (ICT), ensure compliance with EMA/EU GMP requirements, and provide quality oversight for outsourced manufacturing activities in Poland, while also supporting regulatory and quality interactions in Estonia.
Key Responsibilities
- Act as the liaison between ICT and the contract manufacturer (CDMO) in Poland on quality matters
- Build and maintain a client-side Quality Management System (QMS) covering technology transfer, deviations, CAPAs, change control, and complaints
- Review and approve quality documentation from the CDMO: batch records, validation protocols/reports, specifications, stability data
- Participate in and/or host audits and inspections (CDMO qualification audits, regulatory inspections)
- Monitor GMP compliance throughout the MSC manufacturing process, from raw materials to release testing
- Support Quality Agreements (Quality/Technical Agreements) and Statements of Work between ICT and manufacturing/testing partners
- Coordinate quality and regulatory interactions with authorities in Poland (URPL), in alignment with EMA requirements
- Support preparation of CMC/quality sections of regulatory submissions (IMPD, marketing authorization dossier)
- Contribute to risk assessments and quality oversight of the supply chain (raw materials, cold-chain logistics, QC testing labs)
Requirements
- Higher education (pharmaceutical, biotechnology, biology or chemistry).
- Proven experience in QA/QC within pharmaceutical, biotech, or ATMP/cell therapy manufacturing
- Solid knowledge of EU GMP, EMA guidelines, and ATMP-specific regulatory framework (Regulation (EC) 1394/2007)
- Experience working with or within the EU market (Poland experience is a strong plus)
- Familiarity with CDMO relationship management, technology transfer, and Quality/Technical Agreements
- Experience with quality documentation: SOPs, deviations, CAPA, change control, batch record review
- Strong understanding of biologics/cell therapy manufacturing processes and associated risks
- Excellent written and spoken English; Polish and/or Ukrainian is a plus
- Ability to work independently in a remote, cross-border, multi-stakeholder environment
- Strong attention to detail combined with pragmatic, solution-oriented thinking
Nice to Have
- Prior experience with advanced therapy medicinal products (ATMPs) specifically
- Experience interacting with URPL (Poland) or other EU members regulatory authorities
- Background in QP (Qualified Person) or working toward QP status
- Experience with EMA centralized procedure submissions
What We Offer
- Full-time or part-time engagement, fully remote
- Direct involvement in bringing an MSC-based ATMP to the EU market
- Opportunity to shape the quality system of a growing biotech from an early stage
- Flexible collaboration format tailored to the candidate’s availability and expertise
To apply, please send your CV and a short cover note describing your relevant QA/QC and ATMP/EU regulatory experience.
