Director, Quality Assurance (Site Quality Head)

Encoded Therapeutics Inc. is a biotechnology company advancing precision medicines for a broad range of genetic disorders. Our mission is to unlock new opportunities for viral gene therapy through genomics-driven discovery. We focus on delivering life-changing advances for individuals with genetic disorders not addressable with current approaches. For more information, please visit www.Encoded.com.

Encoded Therapeutics is seeking an experienced and vision-driven Director, Quality Assurance to serve as the Site Quality Head for our Research Triangle Park (RTP) clinical manufacturing facility. In this critical leadership position, you will establish, maintain, and oversee all Site Quality Operations, ensuring phase appropriate Quality oversight and compliance with CGMP regulations, internal standards, and global regulatory expectations.

Responsibilities

• Site Quality Leadership & Strategy
• Represent QA in cross-functional team meetings and interacts with Manufacturing, Process Sciences, Facilities & Engineering, Supply Chain, Analytical Sciences, Regulatory, etc. applying strong communication and collaboration skills.
• Maintain updated and relevant knowledge of the GMP landscape, regulations, and guidelines.
• Drive risk-based quality decision-making, and lead escalation and resolution of critical quality events that may impact product supply, data integrity, or patient safety.
• Author, review, and provide technical QA support for site-related sections of regulatory filings and agency interactions.
• Support any site or regulatory body inspections.
• Manage QA team activities to support internal operations, supply chain, quality control, and facilities.
• Lead, mentor, and build a high-performing local Quality Assurance team.
• Trends and reports key quality metrics to the leadership team.
• Quality Operations and Product Disposition
• Provide quality leadership and operational oversight for environmental monitoring, clinical manufacturing (AAV/Gene Therapy), analytical testing, stability, batch record review, and disposition.
• Provide guidance and recommendations to ensure material is manufactured in accordance with established procedures, CGMPs, and appropriate regulations.
• Lead QA oversight for analytical method data review, method validation QA approvals, tech transfer protocol/report reviews, and product specifications.
• Author and revise QA related standard operating procedures and provides guidance for generation, review, and approval of process, equipment, test method, and other SOPs.
• Reviews and approves all GMP related documentation including internal protocols, reports, test records, batch records, labels, specifications and other documents for drug substance.
• Provide oversight and support staff to ensure executed batch records and associated documents to are in compliance with approved procedures and CGMP expectations to determine acceptability of product disposition.
• Review and approve change controls related to the implementation or revision of process, method, and/or equipment changes.
• Provide quality oversight of root-cause analysis and product impact assessment for investigations as a result of deviations, OOS, and OOT investigations ensuring appropriate CAPA actions are identified.
• Support and lead risk assessments to proactively identify, assess, and mitigate site risks.
• Support and maintain the site Contamination Control Strategy (CCS) to mitigate cross-contamination and environmental risks.
• Material and Supply Chain Quality
• Provide quality leadership and operational oversight for raw materials and reagent release, specifications, incoming controls, and storage.
• Lead teams to resolve any non-conforming materials and site supply chain risks.
• Facility and Validation Oversight
• Direct Quality oversight for commissioning, qualification, and validation (CQV) of site facilities, process equipment, automated systems, and analytical instrumentation.
• Oversee site computer system validation (CSV) and data integrity initiatives to comply with 21 CFR Part 11 and global guidelines.
• Provide Quality oversight for facilities, utilities, equipment, and instrument maintenance and management.
• Prioritize projects appropriately and with flexibility to accommodate changing program objectives.
• Identifies opportunities for improvement and drives continuous improvement initiatives.
• Perform other duties and projects as assigned by management.

Requirements

• Education: Bachelor’s degree in Life Sciences or a related discipline, or Master’s degree in Life Sciences or a related discipline.
• Experience: Minimum of 12+ years of progressive Quality Assurance experience in the pharmaceutical, biotechnology, or biologics industry, with at least 5+ years in a senior Quality management leadership role.
• Direct experience in Gene Therapy, Cell Therapy, Viral Vector (AAV), or Advanced Therapy Medicinal Products (ATMPs) is strongly preferred.
• Strong understanding of applicable regulatory requirements and guidance documents (21 CFR, USP, EP, ICH).
• Demonstrated track record of leading successfully through regulatory inspections (FDA, EMA, etc.).
• Demonstrated knowledge of batch disposition, deviation/CAPA management, change control, validation, raw material quality oversight, and environmental monitoring.
• Knowledge of Six Sigma and LEAN, and experience using root cause analysis tools to identify and correct deviations, are a plus.
• Eligible to work in the United States.
• Able to work on-site.