Associate Director, Clinical Quality & GCP/GCLP

Stoke Therapeutics; Bedford (MA); Hybrid; USD 192,000 - 215,000; Full time

Benefits offered by this job

Annual bonus

Equity participation

401K with company match

Unlimited vacation

Tuition assistance

Employee Stock Purchase Program (ESPP)

Job summary

Stoke Therapeutics, headquartered in Bedford, MA, seeks an Associate Director of Clinical Quality Compliance to oversee GCP/GCLP compliance across clinical studies. This role reports to the VP of Quality and collaborates with Clinical Development, Regulatory, and others to ensure regulatory readiness.

The role emphasizes developing quality management systems, risk-based plans, audits, and investigating deviations while maintaining a culture of inspection readiness. Hybrid work in MA with travel.

Qualifications

• BS/BA, MS or PhD with 8+ years in Biotech, Pharma or CRO
• Working knowledge of FDA/EU/ICH GCP and GCLP regulations/guidelines
• Proficient auditing skills with objective evidence and clear findings
• Ability to work autonomously and deliver results on time
• Collaborate effectively in a cross-functional matrix environment
• Strong conflict resolution and negotiation skills
• Ability to manage multiple projects in a fast-paced environment
• Excellent organizational and written communication skills

Responsibilities

• Develop and maintain procedures for GCP/GCLP activities
• Support compliant execution of clinical studies to meet regulatory requirements
• Create data-driven risk-based quality management plans
• Develop GCP/GLP auditing strategies
• Lead internal/external/site audits and drive CAPAs
• Investigate scientific misconduct and regulatory breaches and report findings
• Provide GCP compliance interpretation and training
• Prepare inspection readiness programs and mock inspections
• Support regulatory responses to findings
• Contribute to Stoke's quality culture

Skills

GCP/GCLP knowledge

Auditing

Regulatory interpretation

Cross-functional collaboration

Time management

Communication (oral & written)

Project management

Negotiation/Conflict resolution

Education

BS/BA, MS or PhD

Job description

Stoke Therapeutics, headquartered in Bedford, MA, seeks an Associate Director of Clinical Quality Compliance to oversee GCP/GCLP compliance across clinical studies. This role reports to the VP of Quality and collaborates with Clinical Development, Regulatory, and others to ensure regulatory readiness.

The role emphasizes developing quality management systems, risk-based plans, audits, and investigating deviations while maintaining a culture of inspection readiness. Hybrid work in MA with travel.