Quality Assurance Specialist

Overview

• The Quality Assurance Specialist will oversee compliance and quality assurance for late-stage gene therapy programs.
• This hybrid role requires occasional on-site presence at contract manufacturing organizations.
• Ensure adherence to GMP principles and regulatory requirements in pharmaceutical manufacturing.
• Collaborate with cross-functional teams to resolve quality issues and maintain operational efficiency.
• Contribute to continuous improvement initiatives and refine quality assurance procedures.
• Support deviation management, batch record reviews, and change control processes.
• Provide real-time QA support during manufacturing and aseptic processing operations.
• Partner with stakeholders to ensure alignment on quality expectations and regulatory commitments.

Key Responsibilities & Duties

• Review and assess internal and external deviations, ensuring effective CAPA implementation.
• Perform batch record reviews to ensure compliance with regulatory expectations.
• Provide QA oversight during critical manufacturing and aseptic processing operations.
• Review and approve change controls and notifications, ensuring controlled implementation.
• Collaborate with cross-functional teams to resolve quality issues and align on expectations.
• Contribute to the refinement of QA procedures and templates for GMP operations.
• Identify and implement process improvements to enhance compliance and efficiency.
• Ensure adherence to regulatory requirements for advanced therapy medicinal products.

Job Requirements

• Bachelor’s degree in Biology, Biochemistry, Biotechnology, Engineering, or equivalent experience.
• 8+ years of experience in GMP-regulated environments, preferably with biologics or gene therapy.
• Proficiency in Quality oversight of contract manufacturing organizations.
• Strong understanding of cell and gene therapy manufacturing processes.
• Experience with risk assessments, batch record reviews, and change control systems.
• Knowledge of root cause analysis tools and leading complex investigations.
• Familiarity with FDA, EMA, and ICH regulatory requirements for ATMPs.
• Excellent communication, organizational, and analytical skills.