Senior Director, Quality

Job description

About the Department The Boulder Site is home to the specialized technical operations/CMC team for oligonucleotides and RNAi therapeutics. The CMC team works alongside Quality, Regulatory, Technical Operations and RNAi Early Development professionals at our Boulder, Colorado facility and works closely with our teams in Lexington, Massachusetts. Together, we are driving change. Are you ready to make a difference. The Position: The Senior Director, Quality is the highest quality authority at site Boulder and point of contact for authorities such as e.g. FDA and responsible for qualification and operational readiness of new manufacturing facility for siRNA for Phase I and Phase II to ensure delivery of clinical material from internal GMP plant in 2027 as well as ensuring clinical material delivered and dispositioned from oligo CDMO network to continue ongoing and new clinical trials in the Oligo space. The Senior Director, Quality is responsible for the CMC QA Organization for the Boulder, CO site, which includes responsibility for the Quality Assurance (QA) function, quality oversight, compliance, audits/inspections, validation and quality management systems (QMS) aspects. Develop an...