• Oversee the development, implementation, maintenance, and performance of GCP Quality Assurance systems • Ensure clinical trials and research activities adhere to regulatory requirements and internal policies • Develop and implement risk management strategies to identify, assess, and mitigate risks • Drive initiatives that foster a culture of quality and continuous improvement • Lead investigations of significant complexity and present to executive management • Manage and mentor quality assurance team members • Represent QA at program-wide meetings and provide GCP guidance • Manage quality events, CAPAs, and deviations • Ensure adequate systems and controls are in place for GCP compliance • Execute GCP QA audit program to ensure that processes and systems are adequate for communicating, addressing, and preventing identified GCP compliance issues and trends