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Encoded Therapeutics, a biotechnology company focused on precision medicines and viral gene therapy for genetic disorders, is seeking an experienced Director or Associate Director of Quality Assurance to serve as Site Quality Head for their Research Triangle Park clinical manufacturing facility.
In this leadership role, you will establish and oversee all Site Quality Operations, ensuring phase-appropriate quality oversight and compliance with CGMP regulations, internal standards, and global regulatory expectations. You will represent QA across cross-functional teams including Manufacturing, Process Sciences, Facilities & Engineering, Supply Chain, Analytical Sciences, and Regulatory, driving risk-based quality decision-making and leading escalation of critical quality events impacting product supply, data integrity, or patient safety.
Key responsibilities include: leading and mentoring a high-performing local QA team; providing quality leadership for environmental monitoring, clinical manufacturing (AAV/Gene Therapy), analytical testing, stability, and batch record review; authoring and revising QA-related SOPs; reviewing and approving all GMP-related documentation; overseeing deviation, OOS, and OOT investigations with appropriate CAPA actions; directing quality oversight for commissioning, qualification, and validation of site facilities and equipment; and supporting computer system validation and data integrity initiatives compliant with 21 CFR Part 11.
You will manage material and supply chain quality, lead teams resolving non-conforming materials, and drive continuous improvement initiatives. You will also author, review, and provide technical QA support for regulatory filings and support site and regulatory body inspections.
Required: Bachelor's degree in Life Sciences or related discipline (Master's preferred); minimum 12+ years progressive QA experience in pharmaceutical, biotechnology, or biologics; at least 5+ years in senior QA management leadership. Direct experience in Gene Therapy, Cell Therapy, Viral Vector (AAV), or Advanced Therapy Medicinal Products (ATMPs) is strongly preferred. Strong understanding of 21 CFR, USP, EP, ICH; demonstrated track record leading through FDA/EMA inspections; knowledge of batch disposition, deviation/CAPA management, change control, validation, raw material quality, and environmental monitoring. Six Sigma, LEAN, and root cause analysis tools experience is a plus. Must be eligible to work in the US and able to work on-site.
