Satsuma Pharmaceuticals, Inc.

QA Engineer

• Lead quality strategy and quality management systems through launch and early commercialization in the US
• Oversee GxP quality activities across manufacturing, supply chain, distribution, quality systems, and vendor management
• Ensure inspection readiness and ongoing compliance
• Provide quality leadership for commercial launch readiness
• Oversee batch disposition, product release processes, complaint handling, deviations, CAPAs, change control, and product quality reviews
• Build and maintain a scalable quality management system evolving from clinical-stage to commercial-readiness
• Ensure compliance with FDA, ICH, and global GxP standards
• Establish and oversee commercial quality processes, including final product release/disposition, supply chain security, and distribution quality
• Provide quality oversight for GLP, GCP, and GMP vendors
• Lead vendor qualifications, perform audits, and manage quality agreements with contract manufacturing and research organizations
• Lead deviations, CAPAs, change controls, and quality investigations
• Identify compliance risks and advise executive management on regulatory developments
• Influence executive decision-making on quality and regulatory strategy through data-driven communication
• Develop, implement, and maintain GxP SOPs, policies, and controlled documents
• Establish and manage the company-wide GxP training program
• Oversee product complaint handling, adverse event reporting coordination, and annual product quality reviews (APQR)
• Partner with executive leadership to implement company-wide quality policies and practices
• Lead and develop the quality organization through subordinate managers and team members
• Execute additional responsibilities, initiatives, and special projects as business needs evolve

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Senior Director, Quality Assurance