Senior QSC Manager (m/w/d)
Core
Senior QSC Manager driving Lean culture, regulatory compliance, and GMP coaching for Sterile Drug Product Manufacturing in Mannheim.
Role type
Senior IC Quality & Compliance Manager (Pharma)
Builds
Compliance concepts, regulatory licenses, and inspection readiness for sterile drug products
Domain
Pharmaceutical manufacturing (Sterile Drug Product Manufacturing)
Required skills
GMP compliance, regulatory affairs, inspection management, Lean methodology, project management, stakeholder management, strategic planning, change management, audit coordination, cross-functional leadership
Preferred skills
PhD, experience in production/QA/QC/development, knowledge of EU/FDA/Japanese regulations, global interface management, entrepreneurial mindset
Technologies
Lean tools, GMP frameworks, regulatory databases
Responsibilities
Develop and implement Lean mindset culture and PT behaviors; maintain manufacturing and import licenses as primary regulatory contact; coach functions on GMP and presentation skills for inspections; evaluate GMP activities for regulatory relevance; manage new regulations and compliance trends; lead critical regulatory inspections and audits; advise on EU MDR and Device Combination Product Requirements
Seniority
Senior, hands-on IC with strategic oversight