The organization is oncology focused with 3 commercialized products, and an expanding pipeline of new molecules in development. They manufacture onsite and will focus on early phase programs. As such, they are looking for a driven, experienced, operations focused candidate to join the team as Senior Manager Quality Assurance.
Reports into: Director GMP QA
-Support internal GxP activities (batch release, lot release, investigations)
-Review and approval of SOPs and other manufacturing documentation
-Interface with GMP manufacturing and internal QA team
-B.S. or advanced scientific degree
-9 years experience in pharma/biopharma & 4 years direct quality experience
-Strong background in internal manufacturing and expertise in GMP and/or GLP
-Working knowledge of QA systems, methods, and procedures
-Experience with antibody drug conjugates, oncology, or large molecule is a plus
Sthree US is acting as an Employment Agency in relation to this vacancy.