Manager, Quality Operations
Core
Provide CMC quality oversight of drug substance manufacturing, packaging, and distribution for clinical-stage biopharma products.
Role type
Manager, Quality Operations (CMC)
Builds
Drug substance and commercial products for post-bariatric hypoglycemia, Wolfram syndrome, and ALS treatments.
Domain
Biopharmaceuticals / Peptide and Oligonucleotide manufacturing
Required skills
GMP/GDP compliance, validation document review, batch record review, deviation/OOS/CAPA management, SOP authoring, regulatory filing support, contract partner oversight
Preferred skills
QC experience
Technologies
cGMP, Eudralex, ICH Guidance, FDA regulations
Responsibilities
Review and approve validation documents, master production records, and product specifications; Review executed batch production and QC control records; Prepare and approve batch disposition packages; Review quality system records (deviations, OOS, change controls, CAPAs, complaints); Lead or participate in quality meetings as SME; Write and review SOPs for manufacturing and packaging; Review NDAs and assure source data traceability; Support regulatory agency inspections
Seniority
Manager, hands-on IC