DEPARTMENT: Quality
LOCATION: Durham, NC; Onsite/Not Remote
COMPANY: Humacyte Inc (Nasdaq: HUMA) is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues, advanced tissue constructs, and organ systems designed to improve the lives of patients and transform the practice of medicine. The Company develops and manufactures acellular tissues to treat a wide range of diseases, injuries, and chronic conditions. Humacyte’s initial opportunity, a portfolio of Acellular Tissue Engineered Vessel (ATEVs), is currently approved for use in vascular trauma repair and is in late-stage clinical trials targeting multiple other applications including AV access for hemodialysis and peripheral arterial disease. Preclinical development is also underway in coronary artery bypass grafts, pediatric heart surgery, treatment of type 1 diabetes, and multiple novel cell and tissue applications. Humacyte’s 6mm ATEV for AV access in hemodialysis was the first product candidate to receive the FDA’s Regenerative Medicine Advanced Therapy (RMAT) designation and has also received FDA Fast Track designation. Humacyte’s 6mm ATEV for urgent arterial repair following extremity vascular trauma also received the RMAT designation. For more information, visit www.Humacyte.com.

JOB SUMMARY:

The Senior Director, Quality Assurance (QA) is a key member of the Quality Leadership Team, responsible for providing strategic direction, oversight, and execution of the company’s Quality Management System (QMS). This role ensures compliance with global regulatory requirements (FDA, EMA, ICH, and other applicable health authorities) while fostering a culture of continuous improvement and quality excellence across the organization.
The Senior Director will lead QA teams supporting GxP operations (GMP, GLP, and GCP as applicable), and will serve as a strategic partner to Manufacturing, Supply Chain, Regulatory Affairs, R&D, and Commercial organizations to ensure the highest standards of product quality, patient safety, and regulatory compliance.

EXPERIENCE & QUALIFICATIONS:

• Bachelor’s degree in Life Sciences, Engineering, or related field required; advanced degree (M.S., Pharm.D., Ph.D., or MBA) preferred.
• 15+ years of progressive QA/Quality Systems leadership experience in a Biotechnology-related field, including a minimum of 7 years in senior leadership roles.
• Comprehensive knowledge of global regulatory requirements (FDA, EMA, ICH, ISO, WHO) and cGxP compliance standards.
• Proven track record of leading FDA/EMA inspections with successful outcomes.
• Strong experience managing QA in a multi-site, global, or contract manufacturing environment.
• Demonstrated ability to lead cross-functional teams, influence executive decision-making, and drive organizational change.
• Exceptional communication, leadership, and strategic planning skills.