Standortleiter Quality / Compliance Marburg (m/w/d)
Core
Leading Quality and Compliance operations for pharmaceutical clients, ensuring adherence to GMP, FDA, and ICH standards across project lifecycles.
Role type
Senior site manager (Quality & Compliance)
Builds
Quality and compliance services for pharmaceutical clients
Domain
Pharmaceutical manufacturing / Regulatory compliance
Deliverable
client delivery
Required skills
GMP compliance, Change Control, Data Integrity, Project management, Team leadership, Process optimization, Audit support, Strategic business development
Preferred skills
Aseptic manufacturing experience, Validation expertise, Cross-functional coordination
Technologies
GMP documentation systems, Change Control tools, Project management software
Responsibilities
Lead and develop the Compliance team; Ensure Quality and Compliance services meet EU-GMP, Annex 1, ICH, and FDA requirements; Design and evaluate quality-critical processes; Structure GMP documentation and training concepts; Manage Change Control requests and reporting; Support investment and process optimization projects; Develop new business fields in Quality & Compliance; Build scalable standards and tools; Advise clients on audits and inspections.
Seniority
Senior, hands-on IC with leadership