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Humacyte · 1 day ago

Senior Supplier Quality Lead

Durham, NC

Full-time

Onsite

Senior Level

5+ years exp

Humacyte Inc is developing a disruptive biotechnology platform to deliver universally implantable bioengineered human tissues. The Senior Supplier Quality Lead will oversee supplier audits, manage the Raw Materials release and inspection program, and ensure the timely delivery of critical Raw Materials for commercial manufacturing.

BiotechnologyMedicalMedical Device

No H1B

Responsibilities

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

Qualification

Raw Material programsQuality regulations knowledgeCGMP complianceRoot cause analysisCross-functional communicationAudit trainingTroubleshootingContinuous improvement

Required

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

Strong understanding of regulations and compendial guidance for Raw Material program applications, including USP, EudraLex, PDA technical reports, FDA Guidance for Industry

Strong 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