provide strategic leadership for commercial and clinical stability programs
oversee quality control operations related to contract organizations (CROs/CMOs)
cross functional contribution to define, execute, and harmonize QC strategies
utilize stability trending and statistical analysis software to monitor product performance
work with internal teams, CROs/CMOs to assemble data packages
oversee CDMOs for analytical method development, qualification, and validation
collaborate closely with functional teams to support synthesis and certification
author and/or review QC sections of regulatory submission documents
support pre-approval inspection and commercial readiness activities

BS or equivalent in chemistry or related discipline with 10 – 15 years of relevant industry experience (or MS/PhD with 3 – 5 years of experience)
at least 3 years at the QC Senior Manager level or above
strong understanding and knowledge of cGMP/ICH regulations and USP Guidelines
must thrive working in a fast-paced, innovative environment
proven ability to lead, mentor, and develop QC staff
knowledge of analytical testing concepts in small-molecule Drug Substance and Drug Product
ability to author and review relevant documentation (methods, protocols, reports)
ability to work with all levels of organization and external contract service providers

Associate Director, Quality Control

Key skills