Quality Specialist III QMS

DEPARTMENT:

Quality

Durham, NC, Onsite/Not Remote

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 graft, 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 Quality Specialist III provides Quality oversight and support for Humacyte Quality Management Systems and processes, including documents, training and training metrics, change control, deviations, CAPAs. 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.

• 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 (Master Control).
• 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.

• Minimum 8 years of relevant pharmaceutical, biotechnical or medical device industry experience (including Document Administration, Quality Assurance, Quality Systems, 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
• Experience in writing and owning Deviations, CAPA’s and Change Controls
• Develop and deliver comprehensive training materials, including Standard Operating Procedures, e-learning modules and “Train the Trainer” sessions.
• Minimum 8 years of experience in GMP Quality Management Systems;
  Master Control is a huge plus
• 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…