Description

You will provide quality oversight and expertise to manufacturing and quality control activities, ensuring compliance with GMP and regulatory requirements. You'll review documentation, approve batch records, and drive quality events to closure. This role is critical to maintaining high standards in gene therapy production.

Requirements

• Knowledge of GMP and regulatory requirements
• Experience in quality assurance within pharmaceutical or biotech
• Ability to perform root cause analysis and investigations
• Strong documentation and attention to detail
• Collaboration skills for cross-functional work

Responsibilities

• Quality oversight of manufacturing and QC activities with on-the-floor presence
• Review cleanroom documentation and batch records for accuracy and compliance
• Review and approve raw materials, QC tests, and executed batch records
• Initiate root cause analysis for deviations and environmental excursions
• Initiate, review, and approve CAPAs and change management activities