Senior External QA Specialist — Gene Therapy/CDMO

Encoded-Therapeutics,-Inc.; Morrisville (NC); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Comprehensive benefits package with EP

Stock option grants

PTO, sick time, and holiday pay

Parental leave program

Pre-tax medical and dependent care

STD, LTD, Life and AD&D

Professional development opportunities

Team-building events

Stocked micro-kitchen with drinks and

Wellness Resources

Job summary

Encoded Therapeutics, Inc. is seeking a Sr. Specialist, External Quality Assurance in Morrisville, NC, to lead QA oversight of external CDMOs and ensure cGMP compliance across clinical and commercial supply chains.

You will manage batch disposition reviews, investigations, change governance, and QMS evolution in collaboration with Manufacturing, Process Sciences, and QA teams. The role requires 7+ years in cGMP biotech QA, deep regulatory knowledge, and a proven ability to drive cross-functional

Qualifications

• 7+ years of progressive QA experience in a cGMP-regulated biotechnology environment.
• Experience supporting late-stage clinical manufacturing, commercial quality operations, and tech transfers.
• Deep working knowledge of cGMP standards, international regulations, and regulatory guidance documents (21 CFR Parts 210/211/11, USP, EP, ICH).
• Outstanding ability to lead complex cross-functional root-cause investigations and translate challenges into actionable compliance recommendations.
• Autonomous self-starter capable of navigating a dynamic, fast-paced environment with objective quality decision-making.

Responsibilities

• External Operations Oversight - Drive QA oversight for external CDMO operations, technical transfers, and analytical labs across clinical and commercial supply chains.
• Batch Disposition & Review - Review GMP documentation (batch records, packaging/labeling, sampling plans, specs, testing protocols) for cGMP compliance.
• Complex Investigations - Partner with Manufacturing, Process Sciences, Supply Chain, and QC to resolve deviations, non-conformances, CAPAs prior to batch disposition.
• Change Governance - Review and manage change controls and quality events for process, equipment, facility, and method modifications.
• QMS Implementation & Evolution - Author and refine Quality SOPs; expand site Quality Systems and track metrics.
• Cross-Functional Leadership - Serve as QA voice on cross-functional teams with risk-based compliance guidance.
• Supplier Management & Inspection Readiness - Support supplier onboarding, lifecycle management, audits and regulatory inspection prep.

Skills

Cross-functional collaboration

Regulatory acumen

Root-cause investigations

Autonomy / self-motivation

Communication

Education

Bachelor’s degree in a scientific field

Tools

Veeva Quality Vault

Job description

Encoded Therapeutics, Inc. is seeking a Sr. Specialist, External Quality Assurance in Morrisville, NC, to lead QA oversight of external CDMOs and ensure cGMP compliance across clinical and commercial supply chains.

You will manage batch disposition reviews, investigations, change governance, and QMS evolution in collaboration with Manufacturing, Process Sciences, and QA teams. The role requires 7+ years in cGMP biotech QA, deep regulatory knowledge, and a proven ability to drive cross-functional