Medicines360

QA Engineer

• Provide strategic and operational leadership for Medicines360’s Quality and GXP activities
• Manage the Quality Management System, QA personnel, and quality initiatives
• Create, maintain, review, and approve GXP policies, SOPs, and supporting documents
• Lead QMS programs including change control, deviations and investigations, complaints, CAPAs, metrics, and reporting
• Develop and manage GXP training programs
• Maintain and implement supplier qualification programs, conduct supplier audits, develop quality agreements, and monitor supplier performance
• Implement the internal audit program and support inspection readiness
• Serve as primary backup system administrator for Veeva EDMS and oversee internal EDMS administration
• Manage regulatory inspections and audits with the Head of Quality and Regulatory Affairs
• Develop continuous quality improvement strategies and strengthen the organization’s Quality culture
• Provide Quality and CMC guidance during due diligence, product development, commercialization, clinical studies, and regulatory submissions
• Ensure GCP compliance, supplier qualification, and execution of company SOPs for clinical studies
• Perform product release for investigational and commercial distribution
• Oversee product complaints and review post-marketing surveillance reports
• Manage DHFs and Quality and CMC information for regulatory submissions and information requests
• Participate in supply chain planning and commercial distribution activities
• Monitor the impact of new regulatory requirements on the company, QA function, and product pipeline
• Establish and maintain the internal library of standards and technical publications
• Manage external quality partners, vendors, and consultants
• Manage and mentor QA personnel for career development and advancement

Director of Quality Assurance