Remote Associate Director, GCP Compliance & Quality

Valid8 Financial, Inc.; Kentucky; On-site; USD 140,000 - 190,000; Full time

Benefits offered by this job

Competitive benefits

PTO

Stock options

Job summary

Cabaletta Bio is seeking an Associate Director, GCP Compliance to lead a risk-based QMS aligned with ICH GCP E6(R3). You will oversee documentation, training, vendor quality, TMF readiness, and cross-GxP integration in a fast-paced biotech setting.

Applicants should bring extensive GxP compliance experience, strong communication, and a proactive, independent work style. Remote/hybrid options available in the United States.

Qualifications

• Bachelor’s degree in a scientific discipline.
• Minimum 5–7 years in GxP quality or compliance roles, with at least 2 years in leadership or document control.
• Proven expertise in ICH GCP E6(R3) implementation (risk-based quality management and proportionate vendor monitoring).
• Experience with TMF management, CAPA systems, and inspection readiness.
• Strong understanding of GCP/GMP interfaces and regulatory inspection expectations.

Responsibilities

• Design, implement, and improve a risk-based QMS aligned to ICH GCP E6(R3).
• Oversee controlled document governance and training programs.
• Ensure data integrity and system validation with audit trails.

Education

Bachelor’s degree in a scientific discipline

Tools

SOPs / WIs management

Job description

Cabaletta Bio is seeking an Associate Director, GCP Compliance to lead a risk-based QMS aligned with ICH GCP E6(R3). You will oversee documentation, training, vendor quality, TMF readiness, and cross-GxP integration in a fast-paced biotech setting.

Applicants should bring extensive GxP compliance experience, strong communication, and a proactive, independent work style. Remote/hybrid options available in the United States.