• Develop, implement, and track compliance of QA plans (study, internal process and annual). • Project manage department projects and deliverables to ensure work is of high quality, meets timeline commitments and is well communicated to other stakeholders. • Monitor, evaluate quality indicators, QA reports and audit responses. • Support study operational teams with resolution of escalated issues. • Identify quality GCP risks and work with leaders to design mitigation strategies. • Lead investigations, audits or QA related corporate initiatives and mentor other QA staff in the performance of these activities. • Act as a senior representative of Quality at internal and external meetings. • Support Sponsors, corporate and clinical operational teams with global quality, regulation, ethics, and privacy inquiries. • Remain knowledgeable and current on industry environment and regulatory legislation. • Mentor other QA staff in the support of the development of standard operating procedures. • Serve as a technical role model, motivator, and mentor to the members of the quality team. • Assist the Director with the development of departmental budget activities as the technical expert on audits and associated costs. • Develop and provide training both within the department and external to it.