Early Access Program Quality Assurance Consultant

The Early Access Program (EAP) QA contractor will provide comprehensive, hands-on Quality Assurance (QA) Management and Compliance services for Savara's EAP, including post-trial access, compassionate use, and named patient programs, to provide eligible patients with access to investigational therapy. This person will work cross-functionally and with external EAP vendors. This role is a consultant (1099), expected to work ~140-170 hours/month for 12 months.

• Provide QA GCP oversight of service providers/program(s), ensuring compliance with SOP, GCP, ICH and regulatory requirements
• Identify quality/compliance issues, perform risk assessment, escalate potential risk/issues and actively resolve with key stakeholders
• Serve as QA lead for program related deviations, working with stakeholders to investigate/resolve, identify root cause, and implement appropriate CAPA's along with effectiveness checks
• Partner with service providers and clinical operations to manage on-time deliverables
• Plan, conduct, and/or assist with service provider and site audits as needed based on program requirements
• Perform quality review for program related documentation (i.e., protocol, informed consent, labelling, etc.)
• Support program related regulatory filings by ensuring correct and accurate information
• Review executed packaging/labelling records and QP batch certification as well as perform final disposition of finished product in accordance with Savara procedures
• Extensive understanding and knowledge of QA GCP, GMP and GVP regulations, industry standards, concepts and other health standards/guidance's related to Quality Systems and Quality Assurance is required