The Manager, Clinical QA will be responsible for supporting the Clinical Operations Department, and work collaboratively in the design, execution and reporting of clinical trials at PaxVax, Inc.
• Support Clinical Operations with quality assurance information, as needed.
• Review clinical study reports and regulatory submissions.
• Develop audit plans for appropriate clinical trials.
• Lead and execute clinical site audits.
• Lead and execute internal audits.
• Lead and execute external vendor audits.
• Ensure Investigational Product is shipped and returned according to SOPs and regulations.
• Document all product complaints and deviations related to Investigational Product.
• Review and revise standard operating procedures as required.
• Minimum of Bachelor Degree (BA or BS) required in scientific field.
• Minimum of six (6) years’ experience in a FDA regulated pharmaceutical/biotechnology field.
• Strong understanding and application of cGCPs standards.
• Experience in cGCP QA oversight and auditing roles.
• Experience with effective quality system for a FDA regulated environment.
• Solid computer skills including MS Office required.
Technical Skills and Knowledge:
• Has the ability to make sound decisions based on experience and applicable regulations, i.e. must be able to review, and approved CAPAs, deviations, change controls, etc. with minimal supervision.
• Capable of using an electronic quality management system.
• Has the ability to deal with competing timelines and multiple assignments.
• Strong communication (written and oral), negotiation, organizational, and interpersonal skills.
• Must be able to collaborate and work effectively with multiple departments throughout the organization.
• Must be able to work independently and as part of a team.
• Domestic travel is required (approximately 30%).