The Compliance Audit Manager will be an integral part of a dedicated team that collaborates across various departments to ensure adherence to federal, state, and local regulations, ultimately enhancing patient care and operational integrity. This position is pivotal in overseeing audit and monitoring activities.

This position is responsible for providing product management for the Navitus Medicare Part-D program, leading efforts to design, develop, implement, and oversee various Medicare Part-D processes that align with both client expectations and ensure Navitus meets compliance requirements as defined by the Centers for Medicare and Medicaid Services (CMS).

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 Sr. Regulatory Affairs Specialist is responsible for the preparation of regulatory submissions required to market new or modified medical devices and in vitro diagnostic devices in both domestic and international clinical markets. This entails development, execution and management of procedures and systems designed to ensure that the product development process addresses all regulatory requirements.

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.

Manage and coordinate global clinical trials from study design to closeout, ensuring compliance with ICH-GCP and sponsor SOPs. Collaborate with teams for study execution, risk management, and timely delivery of clinical trial deliverables. Proactively communicate study status, risks, and mitigation strategies to ensure on-time and on-budget execution.

In this role, you will support AG1 growth by ensuring that products are manufactured, labeled, and marketed in compliance with all applicable regulations and laws, primarily in the EU, UK, and other key global regions, while also supporting US regulatory activities as needed.

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.