Vice President, Quality Operations – Combination Products

Role: Vice President of Quality Operations for Combination Products, overseeing quality functions for Dry Powder Inhalation and Soft Mist Inhaler manufacturing sites. Responsibilities: ensure 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. Requirements: Bachelor'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. Preferred: Master’s degree. High-Value: biologics or drug-device combination products; sterile inhalation manufacturing; global GMP compliance; FDA and international regulatory interactions; senior leadership in quality operations. Work setup: on-site RTP, North Carolina; relocation support may be available.