The Senior Clinical Quality Assurance Manager at WEP Clinical oversees the maintenance and compliance of the Quality Management System, ensuring adherence to quality principles and Good Clinical Practice (GCP) regulatory requirements. This role supports key stakeholders across global clinical operations, including clinical trial management and the patient-enabling solutions group. Additionally, the Senior Clinical Quality Assurance Manager is responsible for developing, implementing, and maintaining quality assurance standards

As the Pharmaceutical Global Labeling Lead (GLL), you will be responsible for initial creation and related updated to labeling documents for assigned projects, drive strategy through guidance and advising of the Labeling Team on internal labeling guidance and policies, and ensure compliance with regulatory requirements and delivering high-quality labeling solutions to our clients.

The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level. The CTM will interact well with the HeartFlow Clinical Research staff and collaborate effectively with HeartFlow onsite and field staff, clinical research coordinators, principal investigators, and vendors to aid in ensuring clinical studies meet or exceed timelines and maintain high quality standards. The CTM will have demonstrated experience with clinical research study execution, exceptional organizational skills, excellent attention to detail, and will be comfortable working in a fast- paced start-up culture.

Manage the audit program and supports clinical projects to ensure compliance with regulations and Precision procedures. Manage Quality and Compliance functional activities, including implementation of the QMS, inclusive of SOPs, Training and CAPAs. Work closely with the Quality and Compliance staff and Operations to provide strategic compliance development advice and guidance for optimal conduct of clinical trials.

Play a pivotal role in coordinating Phase 1–3 clinical trials, managing regulatory submissions, and ensuring compliance with FDA, EMA, and other applicable regulations. Support product registration activities and contribute to defining regulatory strategies that align with both domestic and international legislation. Expertise will be instrumental in maintaining current awareness of evolving regulations and communicating significant changes to relevant stakeholders.