Associate Director, Clinical Quality

The Associate Director, Clinical Quality will oversee all aspects of Clinical Quality for internal and external processes, including CROs, vendors, and investigator sites; review internal and external documentation to ensure quality and regulatory compliance; document internal regulatory processes and evaluate quality events, incidents, queries, and complaints; utilize guidance regulatory documents and interpret them for clinical trials; conduct audits of clinical documentation, investigator sites, and vendors; lead root cause analyses and implement corrective and preventive action plans; collaborate with internal and external stakeholders to align quality strategies; assume a lead role in representing clinical quality at meetings and drafting policies and submissions; communicate compliance risks to senior management; assist in the development of documentation and systems; and support the Quality team’s needs while keeping abreast of new regulations and guidelines.