Senior External QA Lead - cGMP & CDMO Oversight

Encoded Therapeutics Inc.; Morrisville (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Competitive benefits package

Stock option grants

PTO, sick time, and holiday pay

Generous 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 to scale from late-stage clinical operations to commercial launch.

You will be the primary QA partner for CDMOs, overseeing cell banks, plasmids, Drug Substance, Drug Product, and Finished Drug Product to ensure cGMP compliance. The role requires cross-functional leadership, regulatory acumen, and hands-on experience with change controls, investigations, and supplier management.

Qualifications

• Bachelor's degree in a scientific or life sciences discipline.
• 7+ years of progressive QA experience in a cGMP biotech environment.
• Clinical & Commercial breadth with support for late-stage manufacturing and tech transfers.
• Deep knowledge of cGMP standards and regulatory guidance (FDA/ICH).
• Strong problem-solving and cross-functional collaboration skills.

Responsibilities

• External Operations Oversight - QA oversight for external CDMO operations and analytical testing laboratories across clinical and commercial supply chains.
• Batch Disposition & Review - Review GMP documentation to ensure full cGMP compliance.
• Complex Investigations - Lead investigations addressing deviations, non-conformances, and CAPAs.
• Change Governance - Review and manage change controls and quality events for process and facility modifications.
• QMS Implementation & Evolution - Author/refine Quality SOPs and track quality metrics.
• Cross-Functional Leadership - Serve as the QA voice on cross-functional teams for regulatory alignment.
• Supplier Management & Inspection Readiness - Onboard suppliers and prepare for regulatory inspections.

Skills

QA Oversight

cGMP Compliance

CDMO Management

Investigations

Regulatory Submissions

Cross-functional Leadership

Vendor Management

Risk-Based Decision Making

Education

Bachelor's degree in life sciences

Tools

Veeva Quality Vault

Job description

Encoded Therapeutics Inc. is seeking a Sr. Specialist, External Quality Assurance to scale from late-stage clinical operations to commercial launch.

You will be the primary QA partner for CDMOs, overseeing cell banks, plasmids, Drug Substance, Drug Product, and Finished Drug Product to ensure cGMP compliance. The role requires cross-functional leadership, regulatory acumen, and hands-on experience with change controls, investigations, and supplier management.