Director, Quality Assurance (Site Quality Head)

About the role

Encoded Therapeutics, a biotechnology company developing precision medicines for genetic disorders, is looking for an experienced Director, Quality Assurance to act as Site Quality Head at its Research Triangle Park clinical manufacturing facility. You will set up, maintain and oversee all site quality operations, ensuring phase-appropriate quality oversight and compliance with CGMP regulations, internal standards and global regulatory expectations.

Key responsibilities

• Represent QA in cross-functional meetings and drive risk-based quality decisions, resolving critical quality events affecting product supply, data integrity or patient safety
• Support regulatory filings, agency interactions and site or regulatory inspections
• Build and lead a local QA team and report quality metrics to leadership
• Oversight of environmental monitoring, clinical manufacturing (AAV/gene therapy), analytical testing, stability, batch record review and disposition
• Approve batch records, change controls, method validations, tech transfers and product specifications, and support root-cause analysis and CAPAs
• Oversee commissioning, qualification and validation, computer system validation and data integrity under 21 CFR Part 11
• Supervise raw material release, incoming controls and storage, and resolve non-conforming materials
• Lead CQV of facilities, equipment and instruments, and maintain the Contamination Control Strategy

Required profile

• Bachelor's or Master's degree in Life Sciences or a related discipline
• Minimum 12+ years of QA experience in pharma, biotechnology or biologics, with at least 5+ years in a senior quality leadership role
• Experience leading through regulatory inspections (FDA, EMA, etc.)
• Eligible to work in the United States and able to work on-site
• Gene therapy, cell therapy, viral vector (AAV) or ATMP experience strongly preferred

Required skills

• Knowledge of 21 CFR, USP, EP and ICH
• Batch disposition, deviation/CAPA management, change control, validation and environmental monitoring
• Six Sigma, LEAN and root cause analysis tools are a plus

What we offer

• Comprehensive benefits with competitive employer premium contributions
• Stock option grants, PTO, sick time, holiday pay and parental leave
• Pre-tax medical and dependent care programs, STD, LTD, life and AD&D insurance
• Professional development, team-building events and a stocked micro-kitchen