Senior QMS & Document Control Specialist – Onsite

NCBioImpact; 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 PTO

10 Holidays + 2 Floating Holidays

Parental Leave Policies

Job summary

Humacyte Inc. is seeking a Senior Quality Specialist to lead GMP Document Control, training, records management, and eQMS oversight. You will ensure compliance with cGMP, cGDocP, and data integrity across controlled documents and records, while supporting inspections and CAPAs.

The role partners with QA, Manufacturing, Validation, Regulatory Affairs, and IT to enhance QMS effectiveness, drive improvements, and maintain inspection readiness in a fast-paced biotech setting.

Qualifications

• Bachelor’s Degree preferred within biotech/pharma or related field.
• Minimum 5–7 years in Quality within biotech, pharma, or medical device.
• Minimum 6–8 years in pharma/biotech/medical device manufacturing with GMP QMS experience.
• Minimum 5 years in GMP Document Control and regulated documentation management.
• Experience with electronic QMS platforms, preferably MasterControl.
• Experience supporting internal audits, regulatory inspections, CAPA, change controls.

Responsibilities

• Serve as SME for GMP Document Control and QMS processes.
• Oversee lifecycle of controlled documentation and retention per procedures.
• Identify compliance gaps and drive standardization and improvements.
• Develop, revise, and approve SOPs, forms, and records within authorization levels.
• Collaborate across QA, Manufacturing, QC, Validation, Regulatory, and IT.
• Support QMS performance metrics and audit readiness.

Skills

GMP Documentation

Records Management

QMS Administration

Data Integrity

Regulatory Inspections

Education

Bachelor’s Degree preferred

High School or GED required

Tools

MasterControl

Job description

Humacyte Inc. is seeking a Senior Quality Specialist to lead GMP Document Control, training, records management, and eQMS oversight. You will ensure compliance with cGMP, cGDocP, and data integrity across controlled documents and records, while supporting inspections and CAPAs.

The role partners with QA, Manufacturing, Validation, Regulatory Affairs, and IT to enhance QMS effectiveness, drive improvements, and maintain inspection readiness in a fast-paced biotech setting.