Senior Director, Quality Control & Regulatory Strategy

Stoke Therapeutics; Bedford (MA); Hybrid; USD 235,000 - 260,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

Medical insurance

401K with company match

Unlimited vacation

Tuition assistance

ESPP

Job summary

Stoke Therapeutics, headquartered in Bedford, MA, is seeking a Sr. Director of Quality Control to lead the end-to-end QC strategy for analytical development, regulatory readiness, and compliance.

This hybrid role partners with CMC, Regulatory, and cross-functional teams to ensure phase-appropriate QC processes and data integrity across early clinical development through commercialization. The ideal candidate has 15+ years in QC leadership, deep GMP/ICH knowledge, and a track record in analytical

Qualifications

• 15+ years of progressive QC leadership experience in late-stage development and commercialization.
• Strong working knowledge of GMP, data integrity, and ICH guidelines.
• Proven expertise in analytical method validation, lifecycle management, and control strategy development.
• Experience with regulatory filings and messaging across global jurisdictions.
• Excellent leadership and cross-functional collaboration skills.

Responsibilities

• Lead Stoke’s global QC strategy across all stages of product development.
• Act as QC SME to senior leadership and cross-functional teams.
• Oversee analytical method lifecycle management including transfer, validation, and stability.
• Manage GMP in-process, release, and stability testing and QC testing strategy.
• Lead CTLs governance, performance, and technical support for QC activities.
• Provide regulatory input for IND/NDA/IMPD/MAA submissions and health authority interactions.
• Ensure data integrity and GMP compliance across QC activities.
• Mature and evolve Stoke’s QC infrastructure and processes for scalable development.

Skills

QC leadership

GMP knowledge

Data integrity

Analytical methods

Cross-functional

Regulatory filings

Leadership

Communication

Education

BS/BA in Analytical Sciences

MS or PhD in Analytical Sciences

Job description

Stoke Therapeutics, headquartered in Bedford, MA, is seeking a Sr. Director of Quality Control to lead the end-to-end QC strategy for analytical development, regulatory readiness, and compliance.

This hybrid role partners with CMC, Regulatory, and cross-functional teams to ensure phase-appropriate QC processes and data integrity across early clinical development through commercialization. The ideal candidate has 15+ years in QC leadership, deep GMP/ICH knowledge, and a track record in analytical