Job Title

Manager, Quality Assurance (QA) & Compliance We are a dynamic Clinical Trial Management Organization (CRO) providing Phase IIIIB full-service support to biotechnology and biopharmaceutical companies. We make a difference by collaborating in life sciences to improve the lives of patients. The Manager, Quality Assurance & Compliance is responsible for maintaining Quality Management Systems (QMS) and practices that align with customer and regulatory requirements. This role involves investigating, analyzing, and reporting compliance activities, as well as participating in sponsor and regulatory audits. Additionally, the Quality Manager will provide training and support to raise awareness and visibility of quality initiatives across the organization. Development and implementation of an annual Quality Plan Conduct internal Quality Control (QC) audits of studies and processes Support investigative site audits and aid sites in preparing for regulatory inspections Deliver current Good Clinical Practice (GCP) and related training to internal and external stakeholders Provide GCP and Quality support to both internal team members and external collaborators Manage, coordinate, and facilitate all sponsor audits and regulatory inspections across multiple jurisdictions, including follow-up and response coordination Manage CAPA processes and reviews, representing Quality as assigned Establish and track trends and metrics related to Quality System processes Support training initiatives related to Quality System requirements and compliance Observe and enforce Quality Policy, Quality Manual, and Quality System Procedures Qualities & Skills: Ability to work effectively under pressure and manage competing priorities Detail-oriented with strong organizational and time-management skills Flexible and able to handle multiple tasks