Head of Quality Control* / Leitung Qualitätskontrolle* (m/w/d)
Core
Leading quality control operations for raw materials and active ingredients, specifically focusing on oligonucleotides, ensuring GMP compliance and laboratory strategy.
Role type
Head of Quality Control (QC)
Builds
GMP-compliant QC laboratory for oligonucleotide-based bulk materials and active pharmaceutical ingredients
Domain
Life Sciences / Pharmaceutical Manufacturing / Oligonucleotide Therapeutics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, laboratory management, team leadership, analytical method validation, OOS investigation, change control, KPI management, budget management, process improvement
Preferred skills
PhD, experience with oligonucleotides, proteins, or peptides, instrumental analysis (HPLC, LC/MS, GC, FT-IR, UV-VIS)
Technologies
HPLC, LC/MS, GC, FT-IR, UV-VIS
Responsibilities
Lead quality control per §12 AMWHV, plan and establish QC lab for oligonucleotides, manage team and training, monitor KPIs and budgets, validate and transfer analytical methods, initiate process improvements, prepare for inspections and audits
Seniority
Senior, hands-on IC with leadership responsibilities