• Plan and conduct audits of suppliers, investigator sites, and internal processes to assess compliance with the applicable regulatory requirements, guidelines, standards, agreements and / or Standard Operating Procedures. • Write and distribute audit reports • Collaborate with cross-functional teams to ensure timely resolution of audit findings and follow up on corrective and preventive actions (CAPAs). • Manage audit scheduling, reporting, and tracking of audit activities, including audits outsourced to third parties • Evaluate the design, feasibility, and operational integrity of clinical trial protocols • Identify gaps or weaknesses in protocol implementation that could impact trial participant safety, data reliability, or regulatory compliance. • Ensure consistent implementation, use and review of SOPs. • Escalate issues to management in a timely manner implementing appropriate solutions, including preventive actions. • Collaborate with internal cross-functional teams to improve quality and increase efficiencies. • Support Ocular Therapeutix Quality Management System (QMS) by assisting with the development and updating of standard operating procedures and other controlled documents. • Lead functional process improvement initiatives to drive efficiencies and effectiveness of Clinical Quality Assurance processes. • Provide guidance and training on GXP regulations, corporate standards, and quality policies • Provide support for inspection readiness and inspections • All other duties as needed or assigned.