Director, Site Quality Assurance & Regulatory Leadership

Encoded Therapeutics; Morrisville (NC); On-site; USD 180,000 - 260,000; Full time

Benefits offered by this job

Stock options

Comprehensive benefits

Paid time off

Parental leave

Pre-tax benefits

Wellness resources

Job summary

Encoded Therapeutics Inc. seeks an experienced Director of Quality Assurance to lead Site Quality Operations at our RTP facility. You will drive CGMP compliance, regulatory readiness, and cross-functional QA alignment to ensure product quality and patient safety.

Ideal candidates have 12+ years in pharma/biotech QA, with 5+ years in senior leadership and direct gene therapy/ATMP experience. On-site leadership and strategic oversight are essential.

Qualifications

• Bachelor's or Master’s in Life Sciences or related field.
• 12+ years of progressive QA experience in pharma/biotech.
• 5+ years in a senior QA leadership role.
• Direct experience in Gene Therapy, Cell Therapy or ATMPs is strongly preferred.
• Strong regulatory knowledge and track record with inspections.

Responsibilities

• Lead Site Quality Leadership & Strategy, liaise with Manufacturing and Regulatory.
• Oversee QA for regulatory filings, risk-based decisions, and inspections readiness.
• Provide quality oversight for environmental monitoring, analytics, and disposition.
• Manage QA teams, drive continuous improvement and CAPA actions.

Skills

QA Leadership

GMP Knowledge

Regulatory Inspections

Cross-functional Collaboration

Risk Management

Education

Bachelor’s degree in Life Sciences or related

Master’s degree in Life Sciences or related

Job description

Encoded Therapeutics Inc. seeks an experienced Director of Quality Assurance to lead Site Quality Operations at our RTP facility. You will drive CGMP compliance, regulatory readiness, and cross-functional QA alignment to ensure product quality and patient safety.

Ideal candidates have 12+ years in pharma/biotech QA, with 5+ years in senior leadership and direct gene therapy/ATMP experience. On-site leadership and strategic oversight are essential.