🛠 Tech Stack

💼 About This Role

You'll ensure robust quality assurance systems for REGENXBIO's pre-clinical and clinical trial operations. You'll oversee audits to maintain GCP, GLP, and GCLP compliance and collaborate with cross-functional teams to support regulatory inspection management. This role offers the chance to work on gene therapy programs in a remote setting.

🎯 What You'll Do

• Develop quality programs and procedures for regulatory compliance
• Review and approve clinical documentation for data integrity
• Conduct and oversee internal and vendor audits
• Manage clinical quality event and CAPA processes

📋 Requirements

• BS in biological science or related field
• 10+ years in Clinical QA or GLP QA role in biopharma
• Extensive knowledge of FDA and EU regulations and ICH guidelines
• Experience conducting and overseeing audits

✨ Nice to Have

• Experience in gene therapy or cellular therapy
• Strong project management skills

🎁 Benefits & Perks

• 🏖️ Remote work flexibility
• 📈 Career development opportunities
• 🧬 Work on cutting-edge gene therapy

🚩 Heads Up

• Vague salary range not provided despite senior role
• Requires 10+ years experience but title suggests director level which may mismatch