Senior Quality Specialist - QMS & Doc Control

Quality Assurance & Systems Full Time North Carolina, Durham, NC, US

3 days ago Requisition

DEPARTMENT: Quality

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.

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The Senior Quality Specialist – Quality Management Systems (QMS) serves as a senior-level subject matter expert responsible for the administration, oversight, continuous improvement, and regulatory compliance of Humacyte’s Quality Management Systems, with primary emphasis on GMP Document Control, Training, Records Management, and electronic Quality Management Systems (eQMS).

This position provides technical expertise and independent oversight of controlled documentation processes, including document creation, revision, approval, issuance, reconciliation, archival, and retention. The Senior Quality Specialist ensures that GMP documentation and associated records are maintained in accordance with applicable regulatory requirements, company policies, established procedures, and data integrity principles.

The individual will serve as a key Quality Systems representative, providing guidance to cross-functional stakeholders, supporting internal and external regulatory inspections, identifying and mitigating compliance risks, and driving process improvements to strengthen QMS effectiveness and operational efficiency.

• Serve as a subject matter expert for GMP Document Control, Records Management, and associated Quality Management System processes.
• Provide independent oversight and administration of regulated documentation throughout the document lifecycle, ensuring compliance with applicable cGMP, cGDocP, data integrity, and internal procedural requirements.
• Assess existing QMS processes to identify compliance gaps, operational inefficiencies, and opportunities for standardization and continuous improvement.
• Develop, revise, review, and approve controlled Quality Systems documentation, including SOPs, Work Instructions, forms, templates, and associated records, within established authorization levels.
• Collaborate with Quality Assurance, Manufacturing, Quality Control, Validation, MSAT, Regulatory Affairs, and other departments to ensure effective implementation and maintenance of Quality Systems.
• Support the development, monitoring, and reporting of Quality Systems performance metrics.

• Oversee the issuance, distribution, reconciliation, archival, retrieval, and retention of controlled documentation in accordance with approved procedures.
• Ensure documentation processes…