Senior Director, Quality Control

Position Purpose

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 ability to build scalable, phase appropriate processes in a lean environment. This person must have a strong working knowledge of relevant FDA, EU, ICH GMP guidelines and regulations for phase appropriate application for product development. A demonstrated ability to think outside of the box with a pragmatic risk-based approach for product development and quality management is essential to this role. The candidate should be willing to roll up their sleeves and directly contribute to the implementation of processes, technical aspects of development and resolution of issues as required. This role will report into The VP of Quality and will partner closely with other cross-functional groups such as CMC Analytical Development, CMC Manufacturing, Regulatory and other functions within Quality.

Key Responsibilities

• Aligned with CMC, establish and lead Stoke's global QC strategy for all stages of product development.
• Act as a QC subject matter expert and thought partner to senior leadership.
• Establish and maintain a phase appropriate analytical control strategy to support clinical development, global regulatory filings, and commercialization.
• Oversee the lifecycle management of analytical methods for oligonucleotide products, including method transfer, qualification, validation, optimization, stability testing, specification justification and maintenance, shelf-life management, reference standard management and remediation.
• Lead the QC group responsible for routine GMP in-process, release, and stability testing, and establish the long-term quality control testing strategy for clinical and commercial programs.
• Lead selection, governance, and performance management of CTLs, ensuring excellence with respect to technical support, compliance, and consistent delivery.
• Partner with CMC, QA, Regulatory Affairs and Program Teams to ensure QC strategies support overall control strategy.
• Provide leadership and technical input into CMC and analytical sections of regulatory submissions (IND, NDA, IMPD, MAA).
• As a QC and analytical expert, support interactions with Health Authorities, Stoke Partners and CTLs.
• Provide GMP compliance interpretation, consultation, training, and ensure data integrity for all QC activities.
• Mature Stokes's QC infrastructure, implementing processes and procedures to support the development of therapeutic candidates in a GMP-compliant manner.
• Drive continuous improvement initiatives across Quality Control.
• Support Stoke's GMP inspection preparation program and mock PAI inspections at CTLs and CMOs as necessary.
• Influence Stoke's Quality culture.
• Lead, mentor, and develop a small team of quality control professionals.

Required Skills & Experience

• BS/BA, MS or PhD in Analytical Sciences or other relevant discipline (i.e., chemistry, biology).
• 15+ years of progressive experience in QC spanning late-stage development and commercialization and with significant leadership responsibility.
• Strong working knowledge of GMP, data integrity principles and ICH guidelines.
• Demonstrated expertise in analytical method validation, lifecycle management, and control strategy development.
• Experience with regulatory filing preparation and messaging across global jurisdictions.
• Proven ability to set high standards for performance and accountability, ensuring clarity of expectations and outcomes.
• Effective in conflict resolution/management and negotiation skills.
• Excellent leadership skills with ability to influence, collaborate and communicate effectively in a cross-functional organization.

Location(s)

Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is a hybrid role with an office setting in Bedford, MA.

Travel

This position will require approximately 20% travel.