Associate Director, Quality Systems

About Stoke:

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

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

The Associate Director, Quality Systems will support the development and maintenance of quality systems for Stoke to ensure compliance with US and international regulations, laws, and guidelines. This person will be accountable for maintaining Stoke’s QMS for product development and clinical trial management. In this role this candidate is required to support change management, audits, and inspections. This person will contribute to maturing and shaping Stoke’s QMS and to meet the various phases of clinical development and product commercialization and life cycle management.

The candidate will influence Stoke’s culture of quality to help reach a sustained state of inspection readiness. This person will report to the Sr. Director of Corporate Quality and will interface closely with other cross-functional groups such as CMC, commercial manufacturing, Regulatory CMC, Regulatory Operations, Regulatory Development, Clinical Operations, Clinical Development, PV, IT and other functions within Quality.

• As the system owner, responsible for managing and administering Stokes QMS.
• Lead QMS changes and process improvements to increase efficiency, effectiveness, continuous improvement, and maintain compliance with evolving GxP regulations and business needs.
• Apply continuous improvement and operational excellence principles to evaluate, redesign, and mature GxP business processes; define system and data requirements and partner with IT to implement
• Collaborate with IT and system users to facilitate risk assessments for new system releases and manage Change Controls for configuration changes to support system enhancements.
• Own the definition and delivery of quality metrics and reporting, including the underlying data and reporting capability within Veeva to support trending and management review.
• Contributes to maintaining Stoke’s Quality Systems program including necessary procedures, records, manuals, and trend reports for the QMS and other quality systems.
• Represent quality on project teams, as needed and provide GMP compliance interpretation, consultation, and other supportive services necessary to maintain and improve compliance and ensure data integrity.
• Administer Stoke’s Audit management program for vendor qualification…