Senior External QA Specialist, CDMO & Regulatory Readiness

Encoded Therapeutics; Morrisville (NC); On-site; USD 120,000 - 170,000; Full time

Benefits offered by this job

Stock options

PTO

Sick time

Holiday pay

Parental Leave

Pre-tax medical

STD

LTD

Life and AD&D

Professional development

Team-building events

Wellness resources

Job summary

Encoded Therapeutics is a clinical-stage genetic medicines company focused on disease-modifying therapies for CNS disorders. We seek a Sr.

Specialist, External Quality Assurance to lead QA oversight of external CDMOs, ensure cGMP compliance, and support regulatory submissions as we scale toward commercial launch. You will collaborate across Manufacturing, Process Sciences, Supply Chain, and QC, author SOPs, and drive continuous improvement in site Quality Systems while guiding cross-functional

Qualifications

• Bachelor’s degree in a scientific or life sciences discipline.
• 7+ years of progressive QA experience in a cGMP-regulated biotechnology environment.
• Experience supporting late-stage clinical manufacturing and commercial quality operations.
• Deep working knowledge of cGMP standards, international regulations, and guidance documents (21 CFR Parts 210/211/11, USP, EP, ICH).
• 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 while maintaining objectivity in quality decisions.

Responsibilities

• External Operations Oversight: Drive QA oversight for external CDMO operations, technical transfers, and analytical testing laboratories across clinical and commercial supply chains.
• Batch Disposition & Review: Provide comprehensive review of GMP documentation including batch records, packaging/labeling documentation, sampling plans, specifications, and testing protocols to ensure full cGMP compliance.
• Complex Investigations: Partner with Manufacturing, Process Sciences, Supply Chain, and QC to investigate and resolve deviations, non-conformances, and CAPAs prior to batch disposition.
• Change Governance: Review and manage change controls and quality events for process, equipment, facility, and method modifications—ensuring commercial readiness and compliance.
• QMS Implementation & Evolution: Author and refine Quality SOPs while contributing to the expansion of site Quality Systems, tracking metrics and presenting trends to leadership.
• Cross-Functional Leadership: Serve as the QA voice on cross-functional teams, offering risk-based compliance guidance and regulatory alignment.
• Supplier Management & Inspection Readiness: Support onboarding and lifecycle management of suppliers, internal/external audits, and regulatory inspection preparations for commercial approval.

Skills

QA leadership

Regulatory knowledge

Root-cause investigations

Autonomous

Education

Bachelor's degree in scientific or life sciences

Tools

Veeva Quality Vault

Job description

Encoded Therapeutics is a clinical-stage genetic medicines company focused on disease-modifying therapies for CNS disorders. We seek a Sr.

Specialist, External Quality Assurance to lead QA oversight of external CDMOs, ensure cGMP compliance, and support regulatory submissions as we scale toward commercial launch. You will collaborate across Manufacturing, Process Sciences, Supply Chain, and QC, author SOPs, and drive continuous improvement in site Quality Systems while guiding cross-functional