Senior Director, Quality Control

10+ years of experience in a GMP-regulated biopharmaceutical environment, including 10+ years in a management or leadership role.

Experience in biologics or cell therapy preferred.

Strong knowledge of cGMP manufacturing and testing requirements for human cells, including 21 CFR 210, 211, 820, and 1271; EudraLex; USP; EP; and ICH guidelines.

Directs the development, validation, planning, implementation, and maintenance of QC product tests and analytical methods, processes, and operations.

Supports the design and execution of the environmental monitoring and sterility assurance programs for GMP manufacturing operations.

Supports development of QC tests and analytical methods that support production, including design support

Validates analytical test methods for raw materials and finished goods

Oversees raw material, in-process and final product release testing.

Responsible for ensuring the appropriate stability programs are initiated and completed to support product development and customer requirements.