Quality Control and Method Validation Manager (m/f/d)
Core
Managing the Quality Control department to ensure compliance with GMP, ICH, and ISO 13485 standards for biotechnology and healthcare solutions.
Role type
Quality Control and Method Validation Manager
Builds
Analytical methods, validation documentation, and sterile pharmaceutical/medical device products
Domain
Biotechnology / Healthcare / Pharmaceutical Manufacturing
Required skills
GMP compliance, method validation, analytical method transfer, stability testing, CAPA management, sterile product knowledge, regulatory documentation, team leadership, contract lab management
Preferred skills
Cleaning validation, active substance residue testing, MS Project, Statistica
Responsibilities
Manage the Quality Control department and ensure process compliance with GMP, ICH, and ISO 13485; Oversee the laboratory, equipment, and quality documentation; Approve specifications, procedures, sampling instructions, and analytical methods; Develop and approve validation documentation and analytical method transfers; Oversee release, stability, and inter-laboratory studies; Lead actions related to deviations, complaints, CAPA, and OOX; Collaborate with contract laboratories and oversee outsourced studies; Make decisions on material and product release or rejection; Ensure appropriate qualification, competency, and training of the Quality Control team; Collaborate with external clients on analytical services
Seniority
Mid-level, hands-on IC