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.

The Associate Director, Clinical Quality Assurance will lead quality oversight of the Adult Phase III Vaccine Program managing a team of 1-4 QA employees and identifying potential risks associated with study design. This role requires a strong knowledge of GCPs, FDA, and EU requirements.

The Start Up Lead is an expert in global site start-up activities and is accountable for the execution of the site start-up strategy and planning. Will act as Subject Matter Expert for questions by other in-country members supporting site start-up activities, Trainer for less-experienced staff on site start-up activities and may be identified as Owner of country specific tools and guidance documents.

Immunovant is seeking a Senior Director, Clinical Quality Assurance (CQA) to serve as a key leader in Quality. This role involves leading Clinical Quality Assurance (CQA), ensuring compliance with global GCP regulations, and contributing to quality systems at a rapidly growing biotechnology company, ensuring patient safety.