of global regulatory CMC strategies for investigational and marketed cell and gene therapy products. This role is accountable...Job Description General Summary: The Director, Regulatory CMC leads a cross-functional team in the execution...
life cycle in Cell & Gene therapy and/or Biologics (ICH/EU/FDA/etc.). · In depth experience in all stages of clinical... justification of specifications, CMC clinical and commercial regulatory submissions. ·Work closely with the cross- functional...
Molecule, Drugs and Biologics and Market Quality (GMP); Cell and Gene Therapy (GMP); Research & Development Quality (GvP, GCP...Job Description The Senior Director, R&D Vendor Quality Management (VQM) is a key leadership role in the Vertex...
. Required Knowledge and Skills: In-depth global regulatory agency knowledge and experience across GXP life cycle in Cell & Gene therapy... cell and gene therapy programs throughout clinical development, commercialization, product launch and post approval...
/globally and across modalities (e.g., small molecule, cell/gene therapy, medical device) Broad and deep quality operations... across modalities (e.g., small molecule, cell, gene, device, biologics), GxP areas, and geographies. Drive continuous improvement...