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 HAVs, is currently in late-stage clinical trials targeting multiple vascular applications, including vascular trauma repair, 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 HAV 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 HAV for urgent arterial repair following extremity vascular trauma also has received an RMAT designation. The HAV received priority designation for the treatment of vascular trauma by the U.S. Secretary of Defense. For more information, visit www.Humacyte.com.

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JOB SUMMARY:

The Quality Specialist III provides Quality oversight and support for Humacyte Quality Management Systems and processes, including documents, training, change control, deviations, CAPAs, and metrics. They will be the single point of contact for various GMP departments on site for day to day and project support and help ensure that GMP areas are compliant and under control. This person will also support internal and external inspections.

ESSENTIAL RESPONSIBILITIES:

• Provide mentorship and support of more junior team members in establishing, maintaining, and monitoring the health of, quality systems.
• Become an SME for the Quality Management System (QMS) and existing eQMS (MasterControl).
• Provide document administration, training coordination, and document issuance support to the site.
• Support metrics development, maintenance, and oversight.
• Support the Quality Records Room and off-site record retention process.
• Develop and maintain site Quality procedures as necessary.
• Collaborate cross-functionally to provide general Quality oversight and support to various departments on site which includes support of routine work, representing Quality Assurance on project teams and in meetings, and reviewing and approving documents.
• Ensure cGMP documents adhere to Humacyte policies, SOPs, and cGMP requirements.
• Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Humacyte quality practices and make informed recommendations for resolution.
• Represent Humacyte Quality by interacting with FDA, partner and supplier auditors/inspectors as needed.
• Other duties, as assigned.

EXPERIENCE & QUALIFICATIONS:

• Minimum 2 years of relevant pharmaceutical, biotechnical or medical device industry experience (includes Document Administration, Quality Assurance, regulated system administration, training development and delivery)
• Background in one or more specialties in biotechnology: pharmaceutical and/or biological development, biomedical engineering, regenerative medicine or chemical engineering
• Minimum 2 years of experience in GMP Quality Management Systems; MasterControl is a huge plus, but not required
• Strong competency with Excel and Word
• Strong background in both written and oral communication with emphasis on effective technical writing
• May be required to work evenings, off-hours, holidays, or extended periods of time.
• Demonstrated background in administration and support of GMP Quality management systems, and related applications
• Experience in evaluating technical quality problems and providing recommendations for corrective actions
• Understanding of clean room operations and aseptic processing, preferred
• Understanding of batch release activities ; prior batch disposition experience, preferred
• Strong understanding of cGMP, GDPs, data integrity requirements, ISO and ICH guidance’s in the biotech manufacturing environment. Understanding of biologics manufacturing operations preferred
• Advanced understanding of Quality Management System strategies and the ability to write SOPs, Work Instructions and related training.

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.