Sr. Specialist, External Quality Assurance

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 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 ofSCN1Afor 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 visitwww.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 - Providecomprehensive reviewof GMP related documentation includingbatch records, packaging/labeling documentation, sampling plans, specifications, and testing protocols to ensure full cGMP compliance.
• Complex Investigations - Partner with Manufacturing, Process Sciences, SupplyChain, and QCto 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 oncross-functionalteams, 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.

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 withAAV, viral vectors, or gene therapy platforms.
• Direct exposure to a successfulBLA/MAA filing, regulatory inspection, or commercial drug approval process.
• Hands-on experience with electronic Quality Management Systems, specificallyVeeva Quality Vault.

• 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.