You will play a critical role in driving the development, implementation, and continuous improvement of training programs designed to ensure excellence in pharmacy and compounding operations. This is a strategic leadership position focused on fostering a culture of compliance, quality, and continuous learning across all levels of the organization. This role collaborates with cross-functional teams to create effective training materials and educational initiatives.

As a Quality Assurance Specialist at Dynavax, you will support activities related to Quality Systems including Document Control, Training, Quality Records Management, Supplier Management, Audits, and Quality Event Management (Deviation, CAPA, Change). This position will support the upgrade implementations and maintenance of the electronic Quality Management System (eQMS) used company-wide.

Oversee Quality Assurance for on-market products from commercialization through end of life, ensuring compliance with all relevant standards and regulations. Maintain Good Documentation Practices (GDP), including product specifications, formula approvals, and audit documentation. Manage Third-Party Testing, coordinating all ongoing testing activities, ensuring appropriate record retention of results, Certificates of Analysis, and other relevant documentation.

Responsible for quality of assigned products which may include small molecule pharmaceuticals and/or biologics products, combination products, and medical devices to ensure business objectives are met with regards to on time delivery of product while assuring compliance to local, divisional, and corporate policies and external agency regulations worldwide. Acts as the primary quality representative for the global supply chain.