Director, Quality Assurance (Site Quality Head)

Encoded Therapeutics • Morrisville, NC

1d • Onsite

About The Position

Encoded Therapeutics is seeking an experienced, vision-driven Director, Quality Assurance to serve as Site Quality Head for its Research Triangle Park clinical manufacturing facility. The role establishes, maintains, and oversees site Quality Operations, providing phase-appropriate quality oversight and ensuring compliance with CGMP regulations, internal standards, and global regulatory expectations. The position leads the local Quality Assurance team and works closely with Manufacturing, Process Sciences, Facilities and Engineering, Supply Chain, Analytical Sciences, Regulatory, and other functions.

The Site Quality Head provides quality leadership and operational oversight across clinical AAV/gene therapy manufacturing, environmental monitoring, analytical testing, stability, batch record review and disposition, materials and supply chain, and facility validation. The role also supports regulatory filings and agency interactions, site inspections, quality systems, investigations and CAPAs, contamination control, computer system validation, and continuous improvement initiatives.

Requirements

• Bachelor’s degree in Life Sciences or a related discipline, or a master’s degree in Life Sciences or a related discipline.
• At least 12 years of progressive Quality Assurance experience in the pharmaceutical, biotechnology, or biologics industry.
• At least 5 years in a senior Quality management leadership role.
• Strong understanding of applicable regulatory requirements and guidance documents, including 21 CFR, USP, EP, and ICH.
• Demonstrated track record of successfully leading through regulatory inspections, such as FDA and EMA inspections.
• Knowledge of batch disposition, deviation/CAPA management, change control, validation, raw material quality oversight, and environmental monitoring.
• Eligible to work in the United States.
• Able to work on-site.

Nice To Haves

• Direct experience in Gene Therapy, Cell Therapy, Viral Vector (AAV), or Advanced Therapy Medicinal Products (ATMPs) is strongly preferred.
• Knowledge of Six Sigma and LEAN.
• Experience using root cause analysis tools to identify and correct deviations.

Responsibilities

• Represent QA in cross-functional team meetings and collaborate with Manufacturing, Process Sciences, Facilities and Engineering, Supply Chain, Analytical Sciences, Regulatory, and other groups.
• Maintain current knowledge of GMP regulations, guidelines, and the broader GMP landscape.
• Drive risk-based quality decision-making and lead escalation and resolution of critical quality events affecting product supply, data integrity, or patient safety.
• Author, review, and provide technical QA support for site-related regulatory filing sections and agency interactions.
• Support site and regulatory body inspections.
• Manage QA team activities supporting internal operations, supply chain, quality control, and facilities.
• Lead, mentor, and build a high-performing local Quality Assurance team.
• Trend and report key quality metrics to the leadership team.
• Provide quality leadership and operational oversight for environmental monitoring, clinical AAV/gene therapy manufacturing, analytical testing, stability, batch record review, and product disposition.
• Guide and advise teams to ensure materials are manufactured in accordance with established procedures, CGMPs, and applicable regulations.
• Lead QA oversight of analytical method data review, method validation approvals, tech transfer protocol and report reviews, and product specifications.
• Author and revise QA standard operating procedures, and guide generation, review, and approval of process, equipment, test method, and other SOPs.
• Review and approve GMP documentation, including internal protocols, reports, test records, batch records, labels, and specifications for drug substance.
• Oversee staff and executed batch records and associated documents to confirm compliance with approved procedures and CGMP expectations and determine product disposition acceptability.
• Review and approve change controls for process, method, and equipment changes.
• Provide quality oversight and support for root-cause analysis and product impact assessments arising from deviation, OOS, and OOT investigations, ensuring appropriate CAPAs are identified.
• Support and lead risk assessments to identify, assess, and mitigate site risks.
• Support and maintain the site Contamination Control Strategy to mitigate cross-contamination and environmental risks.
• Provide quality leadership and operational oversight for raw material and reagent release, specifications, incoming controls, and storage.
• Lead teams in resolving non-conforming material issues and site supply chain risks.
• Direct Quality oversight of commissioning, qualification, and validation of site facilities, process equipment, automated systems, and analytical instrumentation.
• Oversee site computer system validation and data integrity initiatives to meet 21 CFR Part 11 and global guidelines.
• Provide Quality oversight for facilities, utilities, equipment, and instrument maintenance and management.
• Prioritize projects flexibly to accommodate changing program objectives.
• Identify improvement opportunities and drive continuous improvement initiatives.
• Perform other duties and projects as assigned by management.

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.
• Short-term disability, long-term disability, life, and AD&D coverage.
• Professional development opportunities.
• Team-building events.
• Stocked micro-kitchen with drinks and snacks.
• Wellness resources.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior