Associate Director, Quality Control - Technical Services

Role: Associate Director, QC Technical Services – Small Molecule, overseeing GMP release and stability testing at external labs supporting Vertex's commercial small molecule programs. Responsibilities include strategic and operational oversight of QC activities, managing external testing sites, ensuring compliance with SOPs, industry standards, and regulatory guidelines, and handling data review processes for OOS, OOE, and performance trends. The role involves leading cross-functional collaboration with manufacturing, R&D, regulatory, and quality teams, supporting regulatory submissions, and preparing for audits. Qualifications: Master’s degree with 8+ years, or Bachelor’s with 10+ years in pharmaceutical/biopharma industries; extensive experience in analytical chemistry, QC principles, and regulatory compliance (ICH, CFR, FDA) specific to small molecules. Proven leadership in building high-performance teams, managing complex projects, and working with external laboratories is essential. HighValue: Expertise in small molecule chemistry, analytical method development/validation (LC/GC, dissolution, Karl Fischer, FTIR, XRPD), GMP environments, and regulatory interactions. Work setup: hybrid or on-site in a flexible arrangement; travel up to 20%.