As the Director of Quality at Headlands Research, you will oversee quality assurance programs, conduct inspections/audits, and maintain compliance with GCP and regulatory standards. This role involves strategic oversight of the Quality Department, developing SOPs, monitoring KPIs, and ensuring quality incident investigations with CAPA implementation.

This role reports to the Director, GCP QA, supporting all GCP QA needs. Serves as QA primary point of contact for designated clinical studies, attending routine update meetings and ensuring the actioning and completion of study-specific QA activities. Conducts Internal and external (vendor) QA Audits and Reviews, as assigned.

Playing a critical role within Scholar Rock, the Associate Director/Director of Clinical Quality Audits will lead the Clinical Quality Audit Program, develop/implement processes and systems governing the Clinical Quality Audit Program activities and will report into the Senior Director of CQA.

This role is a unique opportunity for an experienced medical coder with a proven track record of leading multi-specialty audits. You will work with clients to establish and maintain medical coding accuracy thresholds, prepare executive presentations, and provide coding insights to engineering and client success teams.