Manager*in GMP Compliance – Oligonukleotide (m/w/d)
Core
Ensure GMP compliance and develop standards for oligonucleotide production.
Role type
Manager, GMP Compliance
Builds
Scalable compliance management systems and risk mitigation frameworks for oligonucleotide manufacturing.
Domain
Life Sciences / Pharma / Oligonucleotide Production
Required skills
GMP regulatory experience, analytical strength, risk analysis, SOP creation, change control management, audit support
Preferred skills
Degree in Chemistry, Pharmacy, or related natural science, experience in GMP-regulated environments, proficiency with quality management systems
Technologies
Quality management systems, MS Office
Responsibilities
Secure highest GMP compliance and continuously develop standards, design efficient and scalable compliance management to minimize risks, analyze deviations and implement corrective measures, identify risks early through targeted risk analyses, create and review SOPs, change controls, and qualification documents, strengthen compliance culture through training and active audit support