Associate Director, GCP Compliance
Cabaletta Bio
August 24, 2026
Remote friendly (All, MO)
United States
Clinical Research and Development
Position Description:
This role can be remote, hybrid or based in Philadelphia, PA headquarters. Reporting to the Senior Director, GCP Quality & Compliance, the Associate Director, GCP Compliance leads the design, implementation, and continuous improvement of a risk-based Quality Management System (QMS) aligned to ICH GCP E6(R3). Ensures oversight of controlled documentation, training, vendor quality, TMF health, and inspection readiness.
Responsibilities:
- Build and maintain a risk-based QMS aligned with E6(R3), emphasizing Critical-to-Quality (CtQ) factors.
- Manage controlled document lifecycles (SOPs, WIs, forms).
- Oversee GxP computerized systems for ALCOA++ compliance (validated configurations, secure audit trails).
- Own role-based training curricula and ensure training effectiveness.
- Lead deviation management, CAPAs, and root cause analysis; perform trend analyses.
- Drive TMF oversight and inspection readiness (risk-based QC, completeness checks, metrics).
- Provide proportionate vendor/CRO oversight; define quality agreements and monitor audit outcomes.
- Align clinical (GCP) and manufacturing (GMP) documentation for traceability and record integrity.
- Develop QMS performance indicators and report during management reviews.
- Promote a culture of quality focused on patient safety and operational transparency.
Qualifications:
- Bachelor’s degree in a scientific discipline.
- 5–7 years in GxP quality/compliance; 2+ years in leadership or document control.
- Proven ICH GCP E6(R3) implementation experience.
- Experience with TMF management, CAPA systems, and inspection readiness.
- Strong understanding of GCP/GMP interfaces and regulatory expectations.
- Experience working with a CRO as a sponsor (preferred).
- Ability to work independently in a fast-paced environment; strong communication and cross-functional skills.
- Biotech/startup experience preferred.
Benefits (explicitly mentioned): competitive benefits, PTO, and stock option plans.
Application instructions:
Visit https://www.cabalettabio.com/join-our-crew to apply.
This role can be remote, hybrid or based in Philadelphia, PA headquarters. Reporting to the Senior Director, GCP Quality & Compliance, the Associate Director, GCP Compliance leads the design, implementation, and continuous improvement of a risk-based Quality Management System (QMS) aligned to ICH GCP E6(R3). Ensures oversight of controlled documentation, training, vendor quality, TMF health, and inspection readiness.
Responsibilities:
- Build and maintain a risk-based QMS aligned with E6(R3), emphasizing Critical-to-Quality (CtQ) factors.
- Manage controlled document lifecycles (SOPs, WIs, forms).
- Oversee GxP computerized systems for ALCOA++ compliance (validated configurations, secure audit trails).
- Own role-based training curricula and ensure training effectiveness.
- Lead deviation management, CAPAs, and root cause analysis; perform trend analyses.
- Drive TMF oversight and inspection readiness (risk-based QC, completeness checks, metrics).
- Provide proportionate vendor/CRO oversight; define quality agreements and monitor audit outcomes.
- Align clinical (GCP) and manufacturing (GMP) documentation for traceability and record integrity.
- Develop QMS performance indicators and report during management reviews.
- Promote a culture of quality focused on patient safety and operational transparency.
Qualifications:
- Bachelor’s degree in a scientific discipline.
- 5–7 years in GxP quality/compliance; 2+ years in leadership or document control.
- Proven ICH GCP E6(R3) implementation experience.
- Experience with TMF management, CAPA systems, and inspection readiness.
- Strong understanding of GCP/GMP interfaces and regulatory expectations.
- Experience working with a CRO as a sponsor (preferred).
- Ability to work independently in a fast-paced environment; strong communication and cross-functional skills.
- Biotech/startup experience preferred.
Benefits (explicitly mentioned): competitive benefits, PTO, and stock option plans.
Application instructions:
Visit https://www.cabalettabio.com/join-our-crew to apply.