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 requirementsIdentify quality/compliance issues, perform risk assessment, escalate potential risk/issues and actively resolve with key stakeholdersServe as QA lead for program related deviations, working with stakeholders to investigate/resolve, identify root cause, and implement appropriate CAPA’s along with effectiveness checksPartner with service providers and clinical operations to manage on-time deliverablesPlan, conduct, and/or assist with service provider and site audits as needed based on program requirementsPerform quality review for program related documentation (i.e., protocol, informed consent, labelling, etc.)Support program related regulatory filings by ensuring correct and accurate informationReview executed packaging/labelling records and QP batch certification as well as perform final disposition of finished product in accordance with Savara proceduresExtensive 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