Senior Supplier Quality Lead

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 Senior Supplier Quality Lead will be assigned supplier audits as well as internal audits and oversee the Raw Materials release and inspection program under support of the Supervisor, Supplier Quality including: logistics and administration needs for 3rd party laboratory confirmation testing of raw Material quality attributes, the incoming Raw Material inspection and release process and ensuring on time delivery of critical Raw Materials for commercial HAV manufacturing.  

ESSENTIAL FUNCTIONS:

With the support of the Supervisor, Suppler Quality:

• Oversee and perform the Raw Material testing program via third-party testing laboratories and contract manufacturers
• Oversee and perform the Raw Material release program via the visual inspection process for raw materials and components received for commercial manufacturing
• Review and approval of OOS and nonconformance investigations for third-party laboratories 
• Review and approval of raw material release documentation including receipt paperwork, supplier certificate of analysis, and third-party testing results against internal specifications, as applicable
• Review and approve SOPs, protocols, specifications, and reports associated with raw material QC programs / procedures, as assigned
• Execute commercial readiness projects and continuous improvement initiatives in preparedness for commercial manufacturing.
• Oversee Raw Materials staff via dotted line reporting
• Create and maintain Raw Material testing schedules and metrics to ensure programs maintain a state of control and continuous material supply is met
• Act as a subject matter expert (SME) and initial point of escalation for Raw Materials team members
• Perform troubleshooting of processes and systems as they arise, guide team members in general troubleshooting, as applicable
• Executes other QA/QC responsibilities, as assigned 
• Provide support for regulatory preparations and inspections
• 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
• Partners with area leaders and subject matter experts for audit activities
• Provides audit and inspection training as needed
• Other duties, as assigned

EXPERIENCE & QUALIFICATIONS:

• High School or GED required, Bachelor’s Degree, preferred
• 5-7 years of experience in Quality within the biotechnology, pharmaceutical, or medical device field, required 
• Minimum 4 years of experience in Raw Material programs, required 
• Prior experience supporting regulatory inspections a plus
• Strong understanding of regulations and compendial guidance for Raw Material program applications, including USP, EudraLex, PDA technical reports, FDA Guidance for Industry
• String understanding of QC Raw Material testing requirements for biological products and application for in-house and outsourced laboratories
• Cross-functional communication and third-party vendor communication is a critical aspect of this position
• General understanding of nature and application of U.S. FDA and European regulations with respect to aseptic processing, biologics manufacturing, and human cell and tissue-based products, including but not limited to: 21 CFR Parts 11, 210, 211, 600, 820, and 1271; and relevant European Directives (2004/23/EC, 2006/17/EC, 2006/86/EC and 2012/39/EU)
• Understanding of cGMP compliance in the biotech/bioprocessing manufacturing environment
• Strong understanding of root cause analysis; change control requirements; Deviation/CAPA and other fundamental elements of Quality Systems
• Position may require working holidays, weekends, and over-time 
• May be required to regularly to 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, as applicable

COMPENSATION & BENEFITS HIGHLIGHTS:

• Stock Options
• 401k Plan with 4% Match and no Vesting Schedule
• Medical, Vision and Dental Plans
• Company Paid Long Term/Short Term Disability
• Company Paid Life Insurance
• 23 Days Paid Time Off (PTO)
• 10 Company Designated Holidays 2 Floating Holidays
• Paid Parental Leave Policies

** Please note, Humacyte does not provide U.S. employment sponsorship and does not accept unsolicited resumes from 3^rd party firms and/or agency recruiters. **

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.