Senior Quality Specialist: QMS & Document Control Leader

Humacyte; Durham (NC); On-site; USD 110,000 - 170,000; Full time

Benefits offered by this job

Stock Options

401k Plan with match

Medical, Vision and Dental

Job summary

Humacyte Inc. is seeking a Senior Quality Specialist focused on QMS and GMP Document Control. You will administer controlled documentation, maintain data integrity, and support regulatory readiness.

The role requires deep knowledge of cGMP, master control practices, and cross-functional collaboration across QA, Manufacturing, Regulatory, and IT. Responsibilities include revising SOPs, managing records, and driving continuous improvement of the Quality Management System.

Qualifications

• Bachelor’s degree in a related field preferred; HS diploma required.
• 5–7 years in Quality within biotech/pharma/medical devices required.
• 6–8 years in GMP QMS environments with strong document control.

Responsibilities

• Serve as SME for GMP Document Control and Records Management.
• Oversee lifecycle of controlled documentation and archival activities.
• Identify gaps and drive standardization and continuous improvement.
• Develop, revise, and approve SOPs, forms, and records.
• Collaborate with QA, Manufacturing, QC, Regulatory, and IT.
• Monitor QMS performance metrics and support audits.

Skills

GMP Documentation

Regulatory Compliance

Quality Systems

Data Integrity

cGMP knowledge

Education

Bachelor’s Degree

High School Diploma

Tools

MasterControl

eQMS

Job description

Humacyte Inc. is seeking a Senior Quality Specialist focused on QMS and GMP Document Control. You will administer controlled documentation, maintain data integrity, and support regulatory readiness.

The role requires deep knowledge of cGMP, master control practices, and cross-functional collaboration across QA, Manufacturing, Regulatory, and IT. Responsibilities include revising SOPs, managing records, and driving continuous improvement of the Quality Management System.