Head of Quality Assurance (m/w/d)
Core
Leading a QA team of ~6 employees and developing the Quality Management System (QMS) for regulatory compliance and efficiency in the pharmaceutical or medical device industry.
Role type
Senior IC Quality Assurance Manager (Regulatory)
Builds
QMS processes, regulatory dossiers, and audit readiness
Domain
Pharmaceutical/Medical Device Industry + Quality Assurance
Required skills
Leadership, QMS development, GMP/GDP compliance, CAPA management, Supplier qualification, Regulatory documentation, System validation, Audit preparation
Preferred skills
Experience in regulated environments, Knowledge of AMG/AMWHV/MedCanG, Fluent German and English
Technologies
GMP, GDP, MedCanG, AmRadV, CTD
Responsibilities
Lead QA team, Develop QMS, Ensure GMP/GDP compliance, Manage CAPA and risk control, Qualify suppliers, Prepare regulatory dossiers, Validate computerized systems, Coordinate audits
Seniority
Senior, hands-on IC