Director, Quality Assurance (Gene Therapy Biotech)

Opus Genetics; Chapel Hill (NC); Sur place; USD 210 000 - 225 000; Plein temps

Avantages offerts par ce poste

Hybrid work arrangement

Résumé du poste

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.

Responsabilités

• 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.

Connaissances

GxP compliance

Audit management

Risk-based quality management

GCP/GMP knowledge

Data integrity

Vendor oversight

Formation

Bachelor's in Life Sciences/Pharmacy

Outils

eQMS

Description du poste

Director, Quality Assurance - Opus Genetics

Overseeing GxP compliance and quality systems for clinical and CMC activities in AAV gene therapy.

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

Requirements

• Bachelor's in Life Sciences, Pharmacy, or related
• 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.

Preferred

• Advanced degrees or certifications
• Experience with eQMS
• Experience with biologics or gene therapy programs

High Value

• Gene therapy, biologics, clinical and CMC GxP, regulatory inspections, risk management, cross-functional leadership
• Durham/remote location, hybrid work
• Salary $210K-$225K