Site Quality Leader — Gene Therapy & Compliance

Encoded Therapeutics Inc.; Morrisville (NC); Vor Ort; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Comprehensive benefits package

Stock option grants

PTO, sick time, and holiday pay

Parental Leave program

Pre-tax medical and dependent care

Professional development opportunities

Team-building events

Zusammenfassung

Encoded Therapeutics Inc. seeks a Director, Quality Assurance to serve as the Site Quality Head for the RTP clinical manufacturing facility.

You will establish and oversee all Site Quality Operations to ensure phase-appropriate QA oversight and CGMP compliance with internal standards and global regulatory expectations. You will lead a cross-functional QA team, drive risk-based decision-making, author regulatory sections, and support inspections.

Qualifikationen

• 12+ years of progressive Quality Assurance experience in the pharmaceutical, biotechnology, or biologics industry.
• 5+ years in a senior Quality management leadership role.
• Direct experience in Gene Therapy, Cell Therapy, Viral Vector (AAV), or ATMPs preferred.
• Strong understanding of applicable regulatory requirements and guidance documents (21 CFR, USP, EP, ICH).
• Demonstrated track record of leading successfully through regulatory inspections (FDA, EMA, etc.).
• Knowledge of Six Sigma and LEAN; experience with root cause analysis tools is a plus.

Aufgaben

• Represent QA in cross-functional team meetings with Manufacturing, Process Sciences, Facilities & Engineering, Supply Chain, Analytical Sciences, Regulatory, etc.
• Drive risk-based quality decision-making and lead escalation of critical quality events
• Author, review, and provide QA support for site-related regulatory filings and agency interactions
• Support site or regulatory inspections and manage QA team activities
• Lead, mentor, and build a high-performing local Quality Assurance team
• Trends and reports key quality metrics to leadership

Jobbeschreibung

Encoded Therapeutics Inc. seeks a Director, Quality Assurance to serve as the Site Quality Head for the RTP clinical manufacturing facility.

You will establish and oversee all Site Quality Operations to ensure phase-appropriate QA oversight and CGMP compliance with internal standards and global regulatory expectations. You will lead a cross-functional QA team, drive risk-based decision-making, author regulatory sections, and support inspections.