Director, Quality Assurance (Site Quality Head)
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 www.Encoded.com.
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 strong 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 pro
