Manager, Quality - QC Analytical

Role: Quality Control Manager overseeing all QC laboratory operations in a pharmaceutical setting, with a focus on compliance, data integrity, and technical leadership. Responsibilities include managing testing across raw materials, in-process, finished products, and stability programs; ensuring regulatory compliance (cGMP, ICH, USP, Ph. Eur., JP); overseeing method validations, transfers, and stability testing; managing external CRO/CMO testing vendors; and maintaining inspection readiness. The role involves technical oversight of analytical equipment, calibration, and validation, as well as audit trail review and investigation authoring for deviations and out-of-specification results. Leadership duties encompass supervising QC chemists, providing technical guidance, training, and cross-functional collaboration, particularly with R&D and manufacturing teams. The manager drives continuous improvement initiatives, supports regulatory submissions, and manages QC metrics and quality risk assessments. Digital strategy responsibilities include overseeing LIMS and electronic notebook implementation and data analytics enhancements. Requirements: 8+ years of analytical chemistry experience in pharmaceutical QC, including at least 1 year of supervisory experience; strong knowledge of HPLC, FTIR, UV/Vis, and analytical method validation; familiarity with global regulatory standards; and excellent data interpretation and communication skills. Preferred qualifications include experience managing external testing vendors. The position is based in San Clemente, CA, with a focus on inspection readiness, technical leadership, and continuous process improvement.