Lead quality assurance initiatives as the Associate Director at Encoded Therapeutics in Research Triangle Park. Oversee all site quality operations while ensuring compliance with CGMP regulations and internal standards.
In this pivotal role, you will establish a vision for quality assurance, manage a high-performing QA team, and engage with cross-functional partners. Your expertise will drive compliance, risk management, and the successful quality oversight of critical manufacturing and analytical operations in gene therapy. Experience in quality compliance and a background in gene or cell therapy will be beneficial.
Key Responsibilities:
• Represent QA in vital cross-functional discussions
• Oversee environmental monitoring and batch record reviews
• Author and revise standard operating procedures
• Manage QA team's activities for internal operations
• Support site inspections and regulatory body interactions
Requirements:
• Bachelor's or Master's in Life Sciences
• 12+ years of experience in Quality Assurance
• 5+ years in a senior quality leadership role
• Knowledge of regulatory requirements and guidance
• Direct experience in Gene Therapy or Advanced Therapies
This role calls for strong leadership in quality assurance within a fast-paced biotechnology workplace.
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📌 Associate Director, Quality Assurance at Encoded (Newfoundland and Labrador)
🏢 Encoded Therapeutics
📍 Newfoundland and Labrador
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