Oversees the development, implementation and maintenance of quality assurance systems, lead initiatives in support of the company goals and implement continuous improvements, including all aspects of GMP and (GXP) compliance. Recommends and provides leadership and planning for the implementation of quality assurance (QA) policies and programs. Oversees generation and review of documents used in good manufacturing practices. Also monitors internal audits of Production, Quality Control, Manufacturing and Development areas. Oversees the vendors audits program. Coordinates interdepartmental activities and partners with Associate Directors of Quality at the other site on predefined timelines for alignment of strategic initiatives and prioritization. Reviews and approves reports and other documentation prepared by Development, Production, QA and QC for regulatory submissions and inspections. Assures finished products are dispositioned in accordance to defined regulatory requirements and Agenus procedures and satisfies GXP regulations. May lead investigations, risk assessment discussions, quality system improvement initiatives and resolve potential product quality issues to improve efficiency. Selects, develops and evaluates personnel to ensure the efficient operation of the function. Works with CMO & CRO partners to ensure trouble free pre-approval and regular Regulatory inspections and interactions. Define system to track and manage metrics in support of Site Management Reviews. Lead intersite initiatives supporting quality goals.
Require BS in chemistry, biology or equivalent science, Master’s degree in science and/or management preferred, 8 -10 years plus Quality Assurance Management and GXP experience.