Senior Director, Quality Control

Stoke Therapeutics

. Provide strategic, scientific and operational leadership for Stoke’s Quality Control function .

Posted 9/22/2026full-timeBedford • Massachusetts • United StatesSenior💰 $235,000 - $260,000 per yearWebsite

Core Competencies

Role fit

Core Competencies

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Demonstrates extensive expertise in Quality Control leadership, including analytical method validation, GMP compliance, and regulatory submission processes. Proven ability to develop and implement global QC strategies while fostering a culture of quality and continuous improvement.

Highest-signal resume keywords

GMP ComplianceAnalytical Method ValidationQuality Control Strategy DevelopmentRegulatory Filing PreparationLeadership in Cross-Functional Teams

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills

Analytical SciencesLifecycle ManagementControl Strategy DevelopmentData Integrity PrinciplesGMP In-Process TestingSpecification JustificationStability TestingOligonucleotide ProductsRegulatory AffairsQuality Control Infrastructure

Soft Skills

LeadershipCollaborationCommunicationConflict ResolutionNegotiation

Industry Keywords

IND SubmissionsNDA SubmissionsIMPD SubmissionsMAA SubmissionsE-VerifyGMP InspectionQuality CultureContract Testing LaboratoriesHealth AuthoritiesContinuous Improvement

About the role

Key responsibilities & impact

Provide strategic, scientific and operational leadership for Stoke’s Quality Control function
Establish and lead the global QC strategy across all stages of product development
Act as a QC subject matter expert and thought partner to senior leadership
Establish and maintain phase-appropriate analytical control strategies for clinical development, regulatory filings and commercialization
Oversee the lifecycle management of analytical methods for oligonucleotide products, including transfer, qualification, validation, optimization, stability testing, specification justification, shelf-life management, reference standard management and remediation
Lead routine GMP in-process, release and stability testing and establish long-term QC testing strategies
Lead selection, governance and performance management of contract testing laboratories (CTLs)
Partner with CMC, QA, Regulatory Affairs and Program Teams on overall control strategy
Provide leadership and technical input into CMC and analytical sections of IND, NDA, IMPD and MAA submissions
Support interactions with Health Authorities, Stoke partners and CTLs
Provide GMP compliance interpretation, consultation and training, and ensure data integrity
Mature QC infrastructure and implement GMP-compliant processes and procedures
Drive continuous improvement across Quality Control
Support GMP inspection preparation and mock PAI inspections at CTLs and CMOs
Influence Stoke’s Quality culture
Lead, mentor and develop a small team of QC professionals
Report to the VP of Quality and collaborate with CMC Analytical Development, CMC Manufacturing, Regulatory and other Quality functions

Requirements

What you’ll need

BS/BA, MS or PhD in Analytical Sciences or another relevant discipline such as chemistry or biology
15+ years of progressive QC experience spanning late-stage development and commercialization, with significant leadership responsibility
Strong working 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
Ability to set high standards for performance and accountability
Conflict resolution, management and negotiation skills
Excellent leadership, collaboration and communication skills in a cross-functional organization
Approximately 20% travel
Participation in E-Verify

Benefits

Comp & perks

Annual bonus
Equity participation
Medical insurance
Dental insurance
Vision insurance
Life insurance
Long- and short-term disability insurance
Paid parental leave
401K plan with company match
Unlimited vacation time
Tuition assistance
Employee Stock Purchase Program (ESPP)
Flexible work arrangements
Employee-led Diversity, Inclusion, and Belonging (DIB) Committee