Senior Director, Quality Control & Regulatory Readiness

Stoke Therapeutics; Tennessee; Hybrid; USD 235,000 - 260,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

Medical, dental, vision

401K with company match

Unlimited vacation

Tuition assistance

ESPP

Job summary

Stoke Therapeutics, a Bedford, MA-based biotech, is seeking a Sr. Director of Quality Control to lead analytical lifecycle management and GMP compliance across development stages.

You will drive control strategies, method validation, and external CMOs collaboration while preparing for regulatory submissions and inspections. The role requires 15+ years in QC, deep GMP knowledge, and strong leadership to influence cross-functional teams and healthcare authorities.

Qualifications

• BS/BA, MS or PhD in Analytical Sciences or other relevant discipline.
• 15+ years of progressive experience in QC spanning late-stage development and commercialization.
• Strong knowledge of GMP, data integrity principles and ICH guidelines.
• Expertise in analytical method validation, lifecycle management, and control strategy development.
• Experience with regulatory filing preparation and messaging across global jurisdictions.

Responsibilities

• Align with CMC to lead Stoke’s global QC strategy for all development stages.
• Serve as a QC subject matter expert to senior leadership.
• Maintain phase-appropriate analytical control strategy to support clinical development and regulatory filings.
• Oversee lifecycle management of analytical methods for oligonucleotide products, including transfer, qualification, validation and stability testing.
• Lead QC group for GMP in-process, release, and stability testing; shape long-term QC testing strategy.
• Lead selection and governance of CTLs, ensuring regulatory compliance and effective delivery.
• Collaborate with CMC, QA, Regulatory, and Program Teams to support QC strategies.
• Contribute to regulatory submissions (IND, NDA, IMPD, MAA) with CMC/analytical input.
• Support interactions with Health Authorities and external CTLs/CMOs.
• Provide GMP compliance interpretation, training, and data integrity across QC activities.
• Mature Stoke’s QC infrastructure with scalable processes for GMP-compliant development.
• Drive continuous improvement across Quality Control; support inspection readiness.
• Mentor and develop a small QC team.

Skills

GMP knowledge

Data integrity

Analytical method validation

Lifecycle management

Cross-functional leadership

Regulatory filings

Communication

Conflict resolution

Education

BS/BA, MS or PhD in Analytical Sciences or related discipline

Job description

Stoke Therapeutics, a Bedford, MA-based biotech, is seeking a Sr. Director of Quality Control to lead analytical lifecycle management and GMP compliance across development stages.

You will drive control strategies, method validation, and external CMOs collaboration while preparing for regulatory submissions and inspections. The role requires 15+ years in QC, deep GMP knowledge, and strong leadership to influence cross-functional teams and healthcare authorities.