Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit Encoded Therapeutics is seeking an experienced and vision-driven Director, Quality Assurance to serve as the Site Quality Head for our Research Triangle Park (RTP) clinical manufacturing facility. In this critical leadership position, you will establish, maintain, and oversee all Site Quality Operations, ensuring phase appropriate Quality oversight and compliance with CGMP regulations, internal standards, and global regulatory expectations. Responsibilities Site Quality Leadership & Strategy Represent QA in cross-functional team meetings and interacts with Manufacturing, Process Sciences, Facilities & Engineering, Supply Chain, Analytical Sciences, Regulatory, etc. applying robust communication and collaboration skills. Maintain updated and relevant knowledge of the GMP landscape, regulations, and guidelines.



Drive risk-based quality decision-making, and lead escalation and resolution of critical quality events that may impact product supply, data integrity, or patient safety. Author, review, and provide technical QA support for site-related sections of regulatory filings and agency interactions. Support any site or regulatory body inspections. Manage QA team activities to support internal operations, supply chain, quality control, and facilities. Lead, mentor, and build a high-performing local Quality Assurance team. Trends and reports key quality metrics to the leadership team. Quality Operations and Product Disposition Provide quality leadership and operational oversight for environmental monitoring, clinical manufacturing (AAV/Gene Therapy), analytical testing, stability, batch record review, and disposition. Provide guidance and recommendations to ensure material is manufactured in accordance with established procedures, CGMPs, and appropriate regulations. Lead QA oversight for analytical method data review, method validation QA approvals, tech

📌 Director, Quality Assurance (Site Quality Head) (Morrisville)
🏢 Encoded Therapeutics
📍 Morrisville