Senior GCP Compliance Lead — QMS & TMF Oversight

Cabaletta Bio; Kentucky; Hybrid; USD 140,000 - 230,000; Full time

Benefits offered by this job

Stock options

Paid time off

Benefits package

Job summary

Cabaletta Bio is seeking an Associate Director, GCP Compliance to design and drive a risk-based QMS aligned with ICH GCP E6(R3). The role oversees documentation, training, vendor quality, and TMF health, enabling inspection readiness across GxP functions.

This role can be remote, hybrid, or based in Philadelphia, PA headquarters, offering a pathway to elevate quality governance and patient safety in a fast-paced biotech environment.

Qualifications

• Bachelor’s degree in a scientific discipline.
• 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 and risk-based quality management.
• Experience with TMF management, CAPA systems, and inspection readiness.

Responsibilities

• Lead the design, implementation, and continuous improvement of a risk-based QMS aligned to ICH GCP E6(R3).
• Oversee controlled documentation, training, vendor quality, TMF health, and inspection readiness.
• Drive deviation management, CAPA, and trend analyses to mitigate risks.
• Coordinate cross-GxP integration and data integrity across study materials and data.

Skills

GxP quality

ICH GCP E6(R3)

TMF management

CAPA systems

Regulatory inspection readiness

Cross-functional collaboration

Education

Bachelor's degree in science

Job description

Cabaletta Bio is seeking an Associate Director, GCP Compliance to design and drive a risk-based QMS aligned with ICH GCP E6(R3). The role oversees documentation, training, vendor quality, and TMF health, enabling inspection readiness across GxP functions.

This role can be remote, hybrid, or based in Philadelphia, PA headquarters, offering a pathway to elevate quality governance and patient safety in a fast-paced biotech environment.