Director of QA, Gene Therapy — GxP Leader (Remote)

Scorpion Therapeutics; Chapel Hill (NC); Hybrid; USD 210,000 - 225,000; Full time

Benefits offered by this job

Hybrid work arrangement

Job summary

Opus Genetics seeks a Director of Quality Assurance to oversee GxP compliance and quality systems for clinical and CMC activities in an AAV gene therapy program. You will lead risk-based QA for clinical development and manufacturing, maintain quality systems, and ensure readiness for regulatory inspections.

Responsibilities include overseeing clinical and supplier quality, leading investigations and CAPAs, and supporting regulatory inspections.

Qualifications

• Bachelor's in Life Sciences, Pharmacy, or related field.
• 10+ years in QA within biotech or pharma.
• Supporting clinical-stage and CMC/GMP processes.
• Vendor oversight and regulatory inspections.
• Skills in GCP, GMP, GxP, Data Integrity, audit management, and risk-based quality management are essential.

Responsibilities

• Lead risk-based QA for clinical development and manufacturing.
• Maintain and improve Quality Systems.
• Oversee clinical and supplier quality.
• Support inspection readiness.
• Lead investigations and CAPAs.

Skills

GxP compliance

Audit management

Risk-based quality management

GCP/GMP knowledge

Data integrity

Vendor oversight

Education

Bachelor's in Life Sciences/Pharmacy

Tools

eQMS

Job description

Opus Genetics seeks a Director of Quality Assurance to oversee GxP compliance and quality systems for clinical and CMC activities in an AAV gene therapy program. You will lead risk-based QA for clinical development and manufacturing, maintain quality systems, and ensure readiness for regulatory inspections.

Responsibilities include overseeing clinical and supplier quality, leading investigations and CAPAs, and supporting regulatory inspections.