RoleVice President of Quality Operations for Combination Products, overseeing quality functions for Dry Powder Inhalation and Soft Mist Inhaler manufacturing sites.
Responsibilitiesensure compliance with GMP/GDP and global regulations across drug and device manufacturing, labeling, and packaging;
lead quality procedures during facility startup, including validation and regulatory filings;
manage Health Authority inspections;
establish quality standards collaboratively with manufacturing;
oversee documentation, risk assessments, CAPAs, and vendor quality agreements;
adapt quality systems for combination products, drive continuous improvement, and support regulatory submissions and compliance strategies.
RequirementsBachelor's in a scientific field;
15+ years in pharma or chemicals quality with growing responsibility;
10+ years managing QA and QC teams;
7+ years in FDA, USP, EP testing;
experience with stability programs, analytical instrumentation (HPLC, GC, UV/VIS, FTIR);
knowledge of US, EU, JP GMPs;
strong leadership, organizational, and regulatory skills.
PreferredMaster’s degree.
High-Valuebiologics or drug-device combination products;
sterile inhalation manufacturing;
global GMP compliance;
FDA and international regulatory interactions;
senior leadership in quality operations.
Work setupon-site RTP, North Carolina; relocation support may be available.
