Senior Quality Systems Specialist - QMS & Document Control

Humacyte Global Inc; Durham (NC); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Stock Options

401k Plan with 4% Match and no Vesting

Medical, Vision and Dental Plans

Company Paid Long Term/Short Term Dis

Company Paid Life Insurance

23 Days Paid Time Off (PTO)

10 Company Designated Holidays + 2浮動

Paid Parental Leave Policies

Job summary

Humacyte Inc in North Carolina seeks a Senior Quality Specialist to manage QMS and GMP document control, training, and records management with an emphasis on eQMS. You will ensure documentation is accurate, complete, and in compliance with data integrity principles.

The role requires collaboration across QA, Manufacturing, Regulatory Affairs, and IT to implement streamlined workflows using MasterControl or equivalent systems, support regulatory inspections, and drive continuous improvement in

Qualifications

• Bachelor’s Degree preferred; high school or GED required.
• 5–7 years in quality within biotech/pharma/medical device.
• 6–8 years in pharma/biotech/biologics or medical device manufacturing with GMP QMS.
• 5+ years in GMP Document Control and regulated documentation management.
• Experience with electronic Quality Management Systems, preferably MasterControl.
• Experience supporting internal audits and regulatory inspections.
• Strong understanding of CFR and FDA Guidance; 21 CFR Parts 210, 211, 11; ICH guidelines.
• Understanding of document lifecycle, records retention, issuance, reconciliation, and archival requirements.

Responsibilities

• Provide SME oversight of GMP Document Control and Records Management.
• Oversee regulated documentation lifecycle ensuring compliance with cGMP and data integrity.
• Identify compliance gaps and drive standardization and continuous improvement.
• Develop and approve SOPs, Work Instructions, forms, templates, and records.
• Collaborate with QA, Manufacturing, QC, Validation, MSAT, Regulatory Affairs and others for effective QMS implementation.
• Monitor and report Quality Systems performance metrics.
• Lead or support training and document control process evaluations.
• Resolve complex documentation discrepancies and ensure proper corrective actions.
• Support electronic QMS workflows and MasterControl configurations and testing.
• Assist with audit responses, investigations and CAPA commitments.
• Promote regulatory compliance and inspection readiness.

Skills

GMP Document Control

Quality Systems administration

Regulated documentation management

eQMS platforms (MasterControl)

Audit support

Regulatory inspections

CAPA

Data integrity

Communication

Root cause analysis

Education

Bachelor’s Degree in a related field

Tools

MasterControl

Job description

Humacyte Inc in North Carolina seeks a Senior Quality Specialist to manage QMS and GMP document control, training, and records management with an emphasis on eQMS. You will ensure documentation is accurate, complete, and in compliance with data integrity principles.

The role requires collaboration across QA, Manufacturing, Regulatory Affairs, and IT to implement streamlined workflows using MasterControl or equivalent systems, support regulatory inspections, and drive continuous improvement in