Manager*in GMP Manufacturing Compliance – Oligonukleotide (m/w/d)
Core
Ensure GMP compliance for oligonucleotide production, from startup preparation through smooth, compliant production runs.
Role type
Manager, GMP Manufacturing Compliance
Builds
Oligonucleotide-based RNA therapeutics
Domain
Life Sciences / Pharma / Oligonucleotide Manufacturing
Required skills
GMP regulatory experience, risk analysis, SOP creation, change control management, audit support, deviation analysis
Preferred skills
Chemistry or Pharmacy degree, MS Office, quality management systems, bilingual German/English
Technologies
MS Office, Quality Management Systems
Responsibilities
Prepare for production start and ensure compliant production runs, scale compliance management and evolve standards, analyze deviations and implement corrective actions, identify risks proactively, create and review SOPs/Change Controls/Qualification documents, conduct training and support audits
Seniority
Manager, hands-on leadership