Sr. Specialist, External Quality Assurance

Encodedgenomics; Morrisville (NC); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Comprehensive benefits package

PTO and holidays

Parental leave

Pre-tax health & dependent care

Job summary

Encoded Therapeutics is seeking a Sr. Specialist, External Quality Assurance in Morrisville, NC to serve as the primary QA partner for CDMOs, overseeing external operations, batch review, and regulatory readiness for clinical and commercial supply chains.

The role requires a BS in a scientific field and 7+ years of cGMP QA experience, with strong regulatory acumen and cross-functional collaboration skills to drive continuous QA improvements.

Qualifications

• Bachelor’s degree in a scientific or life sciences discipline.
• 7+ years of progressive QA experience in a cGMP biotechnology environment.
• Experience supporting late-stage clinical manufacturing and tech transfers.
• Deep knowledge of cGMP standards, FDA/ICH guidance (21 CFR Parts 210/211/11, USP, EP, ICH).
• Ability to lead complex cross-functional investigations and deliver actionable recommendations.
• Autonomous self-starter in a dynamic, fast-paced setting.

Responsibilities

• External Operations Oversight – QA oversight for external CDMO operations, technical transfers, and analytical testing laboratories across clinical and commercial supply chains.
• Batch Disposition & Review – Comprehensive review of GMP documentation to ensure full cGMP compliance.
• Complex Investigations – Collaborate across Manufacturing, Process Sciences, Supply Chain, and QC to resolve deviations and CAPAs prior to batch disposition.
• Change Governance – Review and manage change controls and quality events for process, equipment, facility, and method modifications for commercial readiness.
• QMS Implementation & Evolution – Author and refine Quality SOPs; track quality metrics and leadership trends.
• Cross-Functional Leadership – Serve as the QA voice on cross-functional teams with risk-based compliance guidance.
• Supplier Management & Inspection Readiness – Onboard and manage suppliers, audits, and regulatory inspection preparations.

Skills

Regulatory compliance

Problem-solving

Cross-functional collaboration

Autonomy

Communication

Education

Bachelor's degree in life sciences

Tools

Veeva Quality Vault

Job description

Sr. Specialist, External Quality Assurance

Department:

Quality Assurance

Locations:

Type:

Full time

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.

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 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
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• 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.