Manager, Quality Operations, CMC
Core
End-to-end Product Quality oversight for clinical and commercial pharmaceutical programs, ensuring manufacturing, testing, and release standards for drug substance and product.
Role type
Manager, Quality Operations (CMC)
Builds
Pharmaceutical products (drug substance, solid oral drug product) for patients with central nervous system disorders
Domain
Biopharmaceuticals / Small-molecule drug manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP judgment, risk-based decision making, deviation/OOS investigation, change control, CAPA management, vendor qualification and auditing, batch disposition, regulatory inspection support, technical transfer oversight
Preferred skills
Qualified Person (QP) interface experience, health authority inspection support, external supplier audit leadership
Technologies
GMP compliance frameworks, FDA/EMA/ICH regulatory standards
Responsibilities
Review and approve critical product documentation (specifications, batch records, validation protocols); Lead resolution of deviations, OOS/OOT, temperature excursions, and complaints; Provide Quality oversight of contract manufacturers and service providers; Represent Product Quality in CMC and regulatory teams; Partner across functions to anticipate quality risks and support regulatory filings
Seniority
Manager, hands-on IC with strategic input
