External QA Lead, cGMP & CDMO Oversight

Encodedgenomics; Morrisville (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Comprehensive benefits package

PTO and holidays

Parental leave

Pre-tax health & dependent care

Job summary

Encoded Therapeutics is seeking a Sr. Specialist, External Quality Assurance in Morrisville, NC to serve as the primary QA partner for CDMOs, overseeing external operations, batch review, and regulatory readiness for clinical and commercial supply chains.

The role requires a BS in a scientific field and 7+ years of cGMP QA experience, with strong regulatory acumen and cross-functional collaboration skills to drive continuous QA improvements.

Qualifications

• Bachelor’s degree in a scientific or life sciences discipline.
• 7+ years of progressive QA experience in a cGMP biotechnology environment.
• Experience supporting late-stage clinical manufacturing and tech transfers.
• Deep knowledge of cGMP standards, FDA/ICH guidance (21 CFR Parts 210/211/11, USP, EP, ICH).
• Ability to lead complex cross-functional investigations and deliver actionable recommendations.
• Autonomous self-starter in a dynamic, fast-paced setting.

Responsibilities

• External Operations Oversight – QA oversight for external CDMO operations, technical transfers, and analytical testing laboratories across clinical and commercial supply chains.
• Batch Disposition & Review – Comprehensive review of GMP documentation to ensure full cGMP compliance.
• Complex Investigations – Collaborate across Manufacturing, Process Sciences, Supply Chain, and QC to resolve deviations and CAPAs prior to batch disposition.
• Change Governance – Review and manage change controls and quality events for process, equipment, facility, and method modifications for commercial readiness.
• QMS Implementation & Evolution – Author and refine Quality SOPs; track quality metrics and leadership trends.
• Cross-Functional Leadership – Serve as the QA voice on cross-functional teams with risk-based compliance guidance.
• Supplier Management & Inspection Readiness – Onboard and manage suppliers, audits, and regulatory inspection preparations.

Skills

Regulatory compliance

Problem-solving

Cross-functional collaboration

Autonomy

Communication

Education

Bachelor's degree in life sciences

Tools

Veeva Quality Vault

Job description

Encoded Therapeutics is seeking a Sr. Specialist, External Quality Assurance in Morrisville, NC to serve as the primary QA partner for CDMOs, overseeing external operations, batch review, and regulatory readiness for clinical and commercial supply chains.

The role requires a BS in a scientific field and 7+ years of cGMP QA experience, with strong regulatory acumen and cross-functional collaboration skills to drive continuous QA improvements.