Quality Auditor

Job Description

Job Description

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 Quality Auditor will be responsible for assigned supplier audits, regulatory inspections, and internal audits in accordance with established quality assurance processes, standards, federal and global regulatory guidelines and / or supplier contractual obligations.

ESSENTIAL FUNCTIONS :

• The Quality Auditor will be responsible for assigned supplier audits, regulatory inspections, and internal audits in accordance with established quality assurance processes, standards, federal and global regulatory guidelines and / or vendor contractual obligations
• Independently completes all aspects of supplier audits and internal audits, including, but not limited to, scheduling, documentation preparation, SME coordination, hosting, follow-up responses, and audit closure
• Provide support for regulatory preparation and inspections
• Ensures on-time completion of audit activities with demonstrated interpersonal skills
• Interprets FDA and international regulations, Standard Operating Procedures, and company policies for regulatory compliance
• Maintain continuous education of current regulatory requirements
• Partners with area leaders and subject matter experts for audit activities
• Provides audit and inspection training as needed
• Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety Guidelines
• Maintains and monitors the performance and effectiveness of supplier’s audit program, reporting on the overall achievements of the audit program
• Responsible for initiating and maintaining GMP questionnaires with supplier
• Coordinate with quality, procurement, operations, and R&D to perform supplier audit activities
• Quality Agreements : initiation, review and issuance for commercial and development suppliers
• Quality agreements database review to perform periodic reviews of quality agreements per procedural requirements
• Maintain an Approved Supplier List
• Maintain a Supplier and Internal Audit Schedule

EXPERIENCE & QUALIFICATIONS :

COMPENSATION & BENEFITS HIGHLIGHTS :

The statements in this position profile are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The manager may assign additional responsibilities and assignments from time to time. Humacyte is an equal opportunity employer and is committed to providing equal employment opportunities without regard to age, race, religion, sex, sexual orientation, gender identity, national origin, Veterans status, disability and / or other protected class characteristics. Additionally, Humacyte is committed to achieving its business objectives in compliance with all federal, state and local law.