Associate Director of External QA (Finished Goods) (Contract) at Adverum Biotechnologies, Inc. | Torre
Associate Director of External QA (Finished Goods) (Contract)
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Associate Director of External QA (Finished Goods) (Contract)

Adverum Biotechnologies, Inc.
Emma
Emma
You'll lead global GMP compliance, ensuring product supply integrity to restore vision and prevent blindness.
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Part-time

Legal agreement: Employment

Compensation
USD100 - 110/hour
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Remote (for United States residents)
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Emma of Torre.ai
 30 days ago

Requirements and responsibilities

What you’ll doLeads and participates in cross-functional production teams, internally and externally.Engages, drives, influences, and leads product teams, internal functions, and external partners to ensure Adverum Quality, Manufacturing, financial and program requirements and milestones are met.Drive preparation and successful execution of PPQ and comparability production campaigns.Ensure all quality requirements are planned, completed, and documented in the Quality system.Lead critical investigations, develop and oversee implementation of effective CAPA.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.
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