Biologe (m/w/d)
Core
Developing and maintaining the Quality Management System (QMS) for a stem cell collection center, ensuring compliance with international regulations and supporting internal/external audits.
Role type
Quality Manager (Life Sciences/Pharma)
Builds
Quality Management System (QMS) and compliant processes for stem cell collection
Domain
Life Sciences / Stem Cell Therapy / Regulatory Compliance
Required skills
Quality Management Systems (QMS), CAPA, Change Control, Validation, Supplier Management, Regulatory Compliance (GMP/Drug Law), Auditing, Documentation Management, Analytical Thinking, Conceptual Planning
Preferred skills
GMP environment experience, Pharmaceutical Law knowledge, Computer System Validation (CSV)
Technologies
QMS software, Computerized Systems
Responsibilities
Execute QM processes (document management, training, CAPA, change control, deviations, qualification, validation, supplier management), Update and develop the QM system, Monitor and implement national/international regulations, Participate in accreditation procedures, Assist in internal/external audits, Develop QMS documents, Create quality reports, Support quality questions during system implementation
Seniority
Mid-level, hands-on IC