Adverum Biotechnologies

QA Engineer

• Support a wide variety of GxP activities to support Adverum’s quality compliance initiatives.
• Provide risk-based quality oversight to vendor qualification activities and ensure compliance with internal procedures and documentation.
• Create and manage vendor audit schedules. Conduct audits and interact with vendors to ensure compliance with internal requirements. Ensure vendor packages are complete and inspection ready.
• Assist with executing internal audits and maintaining the internal audit program and ensure compliance with quality objectives and regulatory requirements.
• Assist with regulatory inspections and oversee the inspection readiness plan. Support inspection readiness activities, as directed by QA management.
• Works closely with other functions to assure consistency and implementation of best practices.
• Foster a quality culture and compliance within the team, promoting teamwork, accountability, and continuous learning.
• Perform other responsibilities as assigned by QA management.

QA Compliance Manager – Contract

Project Manager

• Manage functional CMC timelines (e.g. Process Development, External Manufacturing, Quality Control, Quality Assurance, Assay Development), coordinating with functional leads on key tasks to ensure on-track delivery
• Support CMC Lead and functional leads in agenda coordination for team and cross-functional meetings; attend meetings, generating clear minutes with actions and decisions well-documented
• Follow up on action items to ensure progress
• Disseminates and facilitates information flow/exchange among CMC Functions
• Work with team members to escalate constraints, risks, and conflicts via appropriate internal channels
• Provide support for internal reporting, generating materials (e.g. slides, gantt charts, excel sheets) to facilitate discussion and leadership presentations
• Support Research and Non-clinical teams on timelines, ensuring translational work can progress towards GMP Manufacturing and the clinic

QA Compliance Manager – Contract

Project Manager, CMC – Contract