Associate Director, Analytical R&D/AR&D

Job description

Job Title: Associate Director, Analytical R&D/AR&D City: Winchester: State : KY: JOB DESCRIPTION: Develop, implement and communicate a clear strategic vision for quality control to maximize employee focus and develop a competitive advantage. Maintain the highest degree of product quality and quality control systems, grounded by the ability and vision to anticipate and prevent quality and/or regulatory problems. Ensure Quality Control systems are compliant with current FDA, ICH, USP, EP, JP, MHRA, corporate and site procedures as well as industry standards including but not limited to analytical method validations OOS/OOT investigations and root cause analysis, corrective and preventative actions (CAPA), and training. Manage the Quality Control team. Participate in the site Quality Management Review. Oversee analytical investigations and root cause analysis. Oversee the Analytical R&D team for method development, transfers and validations processes to support the introduction of new product pipelines to the site. Facilitate receipt and release processes for the cleaning verifications samples, raw materials, in process samples and finished products. Oversee the laboratory instrument...