Associate Director, Clinical Quality Compliance
Stoke Therapeutics
August 10, 2026
Remote friendly (Bedford, MA)
United States
Clinical Research and Development
Position Purpose:
The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. Reports into the VP of Quality and interfaces with Clinical Development, Clinical Development Operations, DMPK, Regulatory, and Quality functions.
Key Responsibilities:
- Contribute to development and maintenance of GCP/GCLP managed-activity procedures.
- Partner with Clinical Development to support compliant execution of clinical studies and meet regulatory requirements.
- Develop and maintain integrated data-driven risk-based quality management plans.
- Participate in development of GCP/GLP auditing strategies.
- Lead internal/external/investigator site/TMF audits as needed; ensure CAPA implementation.
- Support investigations into scientific misconduct and/or serious breach of GCP; partner with CROs and study teams to identify root/probable cause and ensure CAPAs and appropriate documentation; support timely regulatory reporting.
- Provide GCP compliance interpretation, consultation, training, and supportive services for timely regulatory submissions.
- Establish GCP inspection preparation program and facilitate mock PAI inspections.
- Co-host GCP BIMO/Health Authority inspections; provide input to responses.
- Contribute to development of quality culture.
Required Skills & Experience:
- BS/BA, MS, or PhD with 8+ years’ experience in biotech, pharma, or CRO.
- Working knowledge of relevant FDA, EU, ICH GCP/GCLP regulations and guidelines.
- Proficient auditing skills; identify risks with objective evidence and communicate findings.
- Ability to work autonomously; manage time; deliver results on time.
- Effective cross-functional collaboration.
- Conflict resolution/management and negotiation skills.
- Manage multiple projects in a fast-paced environment.
- Excellent organizational and communication skills.
Benefits:
- Anticipated salary range: $192,000–$215,000; annual bonus and equity participation.
- Medical, dental, vision; life, long- and short-term disability; paid parental leave; 401K match; unlimited vacation; tuition assistance; ESPP.
Application Instructions:
- Apply via https://www.stoketherapeutics.com/careers/
The Associate Director, Clinical Quality Compliance will be a primary quality contact for GCP and GCLP compliance. Reports into the VP of Quality and interfaces with Clinical Development, Clinical Development Operations, DMPK, Regulatory, and Quality functions.
Key Responsibilities:
- Contribute to development and maintenance of GCP/GCLP managed-activity procedures.
- Partner with Clinical Development to support compliant execution of clinical studies and meet regulatory requirements.
- Develop and maintain integrated data-driven risk-based quality management plans.
- Participate in development of GCP/GLP auditing strategies.
- Lead internal/external/investigator site/TMF audits as needed; ensure CAPA implementation.
- Support investigations into scientific misconduct and/or serious breach of GCP; partner with CROs and study teams to identify root/probable cause and ensure CAPAs and appropriate documentation; support timely regulatory reporting.
- Provide GCP compliance interpretation, consultation, training, and supportive services for timely regulatory submissions.
- Establish GCP inspection preparation program and facilitate mock PAI inspections.
- Co-host GCP BIMO/Health Authority inspections; provide input to responses.
- Contribute to development of quality culture.
Required Skills & Experience:
- BS/BA, MS, or PhD with 8+ years’ experience in biotech, pharma, or CRO.
- Working knowledge of relevant FDA, EU, ICH GCP/GCLP regulations and guidelines.
- Proficient auditing skills; identify risks with objective evidence and communicate findings.
- Ability to work autonomously; manage time; deliver results on time.
- Effective cross-functional collaboration.
- Conflict resolution/management and negotiation skills.
- Manage multiple projects in a fast-paced environment.
- Excellent organizational and communication skills.
Benefits:
- Anticipated salary range: $192,000–$215,000; annual bonus and equity participation.
- Medical, dental, vision; life, long- and short-term disability; paid parental leave; 401K match; unlimited vacation; tuition assistance; ESPP.
Application Instructions:
- Apply via https://www.stoketherapeutics.com/careers/