Site QA Director — Gene Therapy GMP Leader

Encodedgenomics; Morrisville (NC); Hybrid; USD 180,000 - 240,000; Full time

Benefits offered by this job

PTO, sick time, holidays

Parental Leave

Pre-tax benefits

Stocked micro-kitchen

Wellness resources

Job summary

Encoded Therapeutics Inc. seeks a Director, Quality Assurance to serve as Site Quality Head for the RTP clinical manufacturing facility. You will establish, maintain, and oversee all Site Quality Operations, ensuring CGMP compliance and alignment with global regulatory expectations.

Responsibilities include leading QA across environmental monitoring, batch release, investigations, and regulatory inspections, while mentoring a high-performing QA team and driving continuous improvement.

Qualifications

• Minimum of 12+ years of progressive quality assurance experience in pharma/biotech/biologics.
• At least 5+ years in a senior quality management leadership role.
• Direct experience with Gene Therapy, Cell Therapy, Viral Vector (AAV) or ATMPs preferred.

Responsibilities

• Lead Site Quality Operations and disposition for CGMP manufacturing.
• Represent QA in cross-functional teams and interactions with Manufacturing, Regulatory, and Supply Chain.
• Drive risk-based quality decisions and escalate critical quality events.

Skills

QA leadership

Regulatory knowledge

Cross-functional collaboration

GMP/GxP

Risk management

Change control

Data integrity

Education

Bachelor’s degree in Life Sciences

Master’s degree in Life Sciences

Job description

Encoded Therapeutics Inc. seeks a Director, Quality Assurance to serve as Site Quality Head for the RTP clinical manufacturing facility. You will establish, maintain, and oversee all Site Quality Operations, ensuring CGMP compliance and alignment with global regulatory expectations.

Responsibilities include leading QA across environmental monitoring, batch release, investigations, and regulatory inspections, while mentoring a high-performing QA team and driving continuous improvement.