Director, QA for QC

Role: Director, QA for QC at a biopharma focused on gene editing therapies, overseeing quality control activities supporting development, manufacturing, testing, and lifecycle management of gene editing products. Responsibilities include providing strategic and operational quality oversight for analytical control strategies, ensuring compliance with GMP regulations and internal standards, leading trending and predictive quality initiatives, managing investigations, and ensuring alignment with regulatory requirements. The role also involves managing external testing partners, supporting lifecycle management of reference standards and stability programs, and leading QC audits and inspections. Additionally, the director mentors QA/QC staff, drives continuous improvement, and oversees compliance and documentation for regulatory filings. Qualifications: MS/PhD in Chemistry, Molecular/Cell Biology, Pharmaceutical Sciences, or related field; 10-12 years of industry experience with biologics, cell, or gene therapies; deep knowledge of GMP testing, analytical techniques (HPLC, CE, bioassays), and regulatory standards (FDA, ICH, USP). Preferred: experience with IND/BLA submissions, commercial QC operations, health authority inspections, and analytical method validation and lifecycle management. High-Value: Expertise in cell/gene therapy or biologics, gene editing modalities, analytical methods, and lifecycle management; experience supporting regulatory filings and commercial scale QC; familiarity with electronic systems (LIMS, EDMS). The position is based at a hybrid location with a focus on building QC maturity for clinical to commercial transition.