Senior Director, Quality Control
Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body’s potential with RNA medicine. Using Stoke’s proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels. Stoke’s first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study. Stoke’s initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency). Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke’s proprietary approach. Stoke is headquartered in Bedford, Massachusetts. For more information, visit https://www.stoketherapeutics.com/
About the role
The Sr. Director, Quality Control, will be responsible for providing strategic, scientific, and operational leadership for the QC function at Stoke. This person is accountable for the end-to-end QC strategy, including analytical control and stability strategy, oversight of external QC operations, and regulatory readiness for early clinical development through late-stage development and commercialization. This person is expected to influence Stoke’s quality culture to help reach a sustained state of inspection readiness for all QC related activities. This person will support the development and execution of Stoke’s GMP Quality Management Plan for compliance and risk monitoring for all analytical activities related to Stoke products. This person will be required to contribute to maintaining a fit for purpose and scalable Quality Management System that is always ready for inspection. The ideal candidate is a seasoned QC leader with expertise in analytical method lifecycle management, can demonstrate the ability to successfully work with CMOs and CTLs, and a proven