Supplier Quality Specialist

About the role

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.

The Supplier Quality Specialist supports the Supplier Quality function through execution of raw material inspection, review, and release activities to ensure timely availability of materials for GMP manufacturing operations. This role performs routine supplier quality activities, supports incoming material disposition, coordinates third-party testing activities, maintains associated quality records, and assists with supplier quality investigations under the guidance of Supplier Quality leadership. This position contributes to maintaining compliance with applicable GMP requirements while supporting continuity of material supply for manufacturing operations.

Responsibilities

• Perform raw material and component release activities in accordance with approved procedures and specifications.
• Review incoming material documentation, including Certificates of Analysis (CoA), Certificates of Conformance (CoC), shipping records, and receipt documentation.
• Coordinate submission of samples to qualified third-party testing laboratories and track testing status to support material release timelines.
• Review third-party laboratory test reports against approved specifications and escalate discrepancies, atypical results, or quality concerns.
• Execute incoming inspection activities for raw materials and components as required.
• Maintain raw material release records, inspection documentation, and associated quality system documentation.
• Assist with supplier investigations, nonconformances, deviations, complaints, and supplier corrective actions (SCARs).
• Support supplier qualification and monitoring activities through collection and maintenance of supplier quality documentation.
• Generate and maintain raw material release metrics and reporting tools.
• Participate in continuous improvement initiatives related to material release processes and supplier quality programs.
• Support internal audits, supplier audits, and regulatory inspections by providing documentation and subject matter support, as assigned.
• Assist in the review and revision of SOPs, forms, specifications, and work instructions associated with raw material programs.
• Support inventory disposition decisions through accurate and timely execution of release activities.
• Perform other Quality Assurance responsibilities as assigned.

Qualifications

• High School or GED required; Bachelor’s Degree preferred.
• 2‑4 years of experience in Quality within the biotechnology, pharmaceutical, or medical device field (required).
• Minimum 2 years of experience in Raw Material programs (required).
• Prior experience supporting regulatory inspections a plus.
• May require working holidays, weekends, and overtime.
• May be required to regularly sit; stand for prolonged periods of time.
• May spend time in a manufacturing operations environment and will be required to meet applicable gowning and personal protective equipment guidelines.
• Strong understanding of regulations and compendial guidance for Raw Material program applications, including USP, EudraLex, PDA technical reports, FDA Guidance for Industry.
• Working knowledge of cGMP regulations and quality system requirements.
• Understanding of raw material release processes and controlled documentation practices.
• Ability to review quality records for accuracy, completeness, and compliance.
• Familiarity with supplier documentation including Certificates of Analysis, specifications, and testing requirements.
• Ability to coordinate activities with Manufacturing, Warehouse, QC, Supply Chain, and external testing laboratories.