Adverum Biotechnologies

QA Engineer

• Assess and optimize Quality systems and processes for CMC, Clinical, Regulatory, and IT.
• Drive complete cross-functional adoption of Quality systems and ensure excellence in execution and performance of the Quality systems through active participation and leadership.
• Provide strategic support and leadership for corporate initiatives, particularly regarding product supply integrity and global GMP compliance.
• Actively partner with cross-functional leadership to address challenges, develop solutions, and execute plans for integration with corporate systems and preparation for commercial stage support.
• Represents Quality in both internal and external operational forums.
• Leads and participates in Quality function and cross-functional teams, focusing on ensuring success in accomplishing objectives through practice of Adverum values and behaviors.
• Leverages Continuous Improvement tools and processes to drive efficiencies in delivery of quality product and execution of the Quality Management System.
• Stays abreast of evolving multi-regional regulatory requirements and develops strategies to assess and update internal quality processes accordingly.
• Provides support for internal and regulatory audits and inspections.
• Develops and implements processes and criteria to assess effectiveness of quality initiatives.
• Supports periodic presentation of company quality metrics for management reviews.
• Other duties as assigned.

Director, QA Systems – Contract

Manager

• Oversee day-to-day operations at contract manufacturing sites to ensure production targets are met and quality standards are maintained.
• Serve as the secondary point of contact between Adverum and CMO (s), ensuring clear and effective communication.
• Monitor and assess the performance of contract manufacturing partners, implementing improvement plans as needed.
• Coordinate with contract manufacturers to schedule production runs, ensuring that products are manufactured on time and within budget.
• Monitor production processes to ensure compliance with company specifications, regulatory requirements, and industry standards and current best practices.
• Address and, if needed, escalate any production issues or delays promptly, working with contract manufacturers to develop and implement solutions.
• Review and approval of manufacturing documentation (MBRs, specifications, change controls, deviations, etc.)
• Ensure that all products manufactured at contract sites meet Adverum’s quality standards and comply with relevant regulations.
• Collaborate with Quality Assurance teams to schedule audits, inspections, and quality checks at contract manufacturing sites.
• Monitor corrective and preventive actions (CAPA) that are implemented to address any quality issues or deviations from standards.
• Work closely with the Supply Chain team to manage the flow of materials and finished products between Adverum and CDMO(s).
• Ensure that contract manufacturers have the necessary raw materials, equipment, and resources to meet production needs.
• Monitor inventory levels at contract sites to prevent stock-outs or excess stock of any required materials.
• Monitor and manage production costs at contract manufacturing sites to ensure alignment with budgetary goals.
• Identify opportunities for cost savings and efficiency improvements in the manufacturing process.
• Ensure that all manufacturing activities at contract sites comply with applicable regulations, including GMP, FDA, ISO, and other relevant standards.
• Maintain up-to-date knowledge of regulatory requirements and industry best practices.
• Lead efforts to implement and maintain compliance programs at contract manufacturing sites.
• Drive continuous improvement initiatives at contract manufacturing sites to enhance product quality, production efficiency, and operational effectiveness.
• Collaborate with cross-functional teams to identify and implement process improvements.
• Track and report on key performance indicators (KPIs) related to contract manufacturing performance.
• Identify and mitigate risks associated with contract manufacturing operations, including supply chain disruptions, quality issues, and regulatory compliance challenges.
• Develop contingency plans to address potential disruptions and ensure continuity of supply.

Director, QA Systems – Contract

CDMO Manager, External Manufacturing – Contract