Sr. Specialist, External Quality Assurance

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 is a clinical-stage genetic medicines company developing potentially disease-modifying therapies to improve the lives of people with severe CNS disorders. Our proprietary vector engineering approach combines novel regulatory elements and payloads with AAV vectors to unlock innovative solutions for debilitating, intractable CNS conditions. At the forefront is our flagship clinical program, ETX101 for Dravet syndrome, which targets the underlying cause of the disorder to enable highly selective upregulation of SCN1A for potentially long-lasting benefit. In parallel, we are advancing a pipeline of potentially best‑in‑class programs to address significant unmet needs across both monogenic and prevalent CNS conditions. For more information, please visit www.encoded.com.

The Sr. Specialist, External Quality Assurance is pivotal role within our Quality organization that offers a unique opportunity to shape our external QA framework as we scale from late-stage clinical operations to commercial launch. You will serve as the primary QA partner for our Contract Development and Manufacturing Organizations (CDMOs), providing rigorous oversight of cell banks, plasmids, Drug Substance, Drug Product, and Finished Drug Product. We are seeking a proactive QA professional with a track record of driving cross‑functional alignment, managing external vendor relationships, and supporting successful regulatory submissions/approvals.

Responsibilities

• External Operations Oversight - Drive QA oversight for external CDMO operations, technical transfers, and analytical testing laboratories across both clinical and commercial supply chains
• Batch Disposition & Review - Provide comprehensive review of GMP related 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 continuous expansion of site Quality Systems, tracking key quality metrics, and presenting performance trends to leadership
• Cross‑Functional Leadership - Serve as the QA voice on cross‑functional teams, offering clear, 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 as we prepare for commercial approval

Requirements

Core Qualifications

• Education - Bachelor's degree in a scientific or life sciences discipline (e.g., Biology, Chemistry, Biochemistry)
• Experience - 7+ years of progressive QA experience in a cGMP-regulated biotechnology environment
• Clinical & Commercial Breadth - Demonstrated experience supporting late-stage clinical manufacturing, commercial quality operations, and tech transfers
• Regulatory Acumen - Deep working knowledge of cGMP standards, international regulations, and regulatory guidance documents (21 CFR Parts 210/211/11, USP, EP, ICH)
• Problem-Solving & Collaboration - Outstanding ability to lead complex cross‑functional root‑cause investigations and translate technical challenges into actionable compliance recommendations
• Mindset - Autonomous self‑starter capable of navigating a dynamic, fast‑paced environment while maintaining complete objectivity in quality decision‑making

Preferred Qualifications

• Direct experience with AAV, viral vectors, or gene therapy platforms
• Direct exposure to a successful BLA/MAA filing, regulatory inspection, or commercial drug approval process
• Hands‑on experience with electronic Quality Management Systems, specifically Veeva Quality Vault

Benefits

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre‑tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities
• Team‑building events
• Stocked micro‑kitchen with drinks and snacks
• Wellness Resources

Encoded is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. Encoded is committed to the principle of equal employment opportunity for all employees and to providing employees with a work environment free of discrimination and harassment. All employment decisions at Encoded are based on business needs, job requirements and individual qualifications, without regard to race, religion or belief, color, national origin, gender, status as a protected veteran, status as an individual with a disability, or any other status protected by the laws or regulations in the location in which we operate. Encoded will not tolerate discrimination or harassment based on any of these characteristics. Encoded encourages applicants of all ages.