About the role
Job Title : Associate Director, Quality Location : Hybrid Reports to : Vice President, Head of Regulatory and Quality Full/Part-Time : Full-Time Regular/Temporary : Temporary 6 months, with possibility of 6-month extension Job Summary The Associate Director of Quality is responsible for managing quality assurance activities, providing strategic oversight of the implementation of a Quality Management System (QMS), and ensuring compliance with FDA, ICH, and other regulatory standards. This individual ensures compliance with GxP regulations (GLP, GMP, GCP as applicable) across our CROs. The successful candidate will establish quality frameworks from the ground up and lead quality initiatives that support the company's pipeline from preclinical research through clinical development in a fast-paced, resource-conscious environment. What You Will Do: Quality Program Development Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, GCP ) Implement pragmatic quality approaches that balance compliance with operational efficiency Create quality culture and awareness across all organizational levels Excellent leadership, communication, and interpersonal skills CRO Management & Strategic Partnerships Serve as the co-primary quality liaison for CDMO partnerships, overseeing quality agreements, audits, and ongoing compliance activities. Implement risk-based CRO oversight programs optimized for resource efficiency Build strong working relationships with CRO quality teams to ensure seamless collaboration Manage CRO performance with emphasis on speed, quality, and value delivery Quality Systems & Documentation Develop, implement, and maintain quality systems and procedures to ensure compliance with applicable regulations (GLP, GMP, GCP.). Ensure proper documentation and record-keeping practices Lead development of standard operating procedures (SOPs) and work instructions Maintain document control and change management processes Review key quality documentation, including protocols, reports, SOPs, batch records, and laboratory data. Technical
