Senior QMS & Document Control Lead (GMP MasterControl)

Regulatory Jobs; Durham (NC); On-site; USD 110,000 - 140,000; Full time

Benefits offered by this job

Stock Options

401k 4% Match

Health Insurance (Medical, Vision, T&D

PTO 23 Days

Holidays & Parental Leave

Job summary

Humacyte Inc. in Durham, NC, seeks a Senior Quality Specialist to lead GMP Document Control, Records Management and eQMS oversight. You will ensure regulatory compliance, data integrity, and alignment with company policies across QA, Manufacturing and Regulatory Affairs.

The role focuses on controlled documentation, training, and archival lifecycle, driving improvements and supporting internal and external inspections. A strong background in GMP/QMS is essential.

Qualifications

• Bachelor's degree required.
• 5–7 years of quality experience in biotech/pharma/med device.
• 6–8 years in pharmaceutical/biotech manufacturing environments with GMP QMS exposure.
• 5 years in GMP document control and regulated documentation management.
• Experience with electronic QMS, preferably MasterControl.

Responsibilities

• Serve as SME for GMP Document Control, Records Management and QMS processes.
• Oversee documentation lifecycle and archival in compliance with cGMP and data integrity.
• Identify gaps, drive standardization and continuous improvement.
• Develop, revise, review, and approve SOPs, work instructions, forms and records.
• Support audits, CAPA, investigations and regulatory inspections.

Skills

QMS administration

GMP documentation

Regulatory inspections

Data integrity

Document lifecycle

Education

Bachelor’s Degree

Tools

MasterControl

eQMS platforms

Job description

Humacyte Inc. in Durham, NC, seeks a Senior Quality Specialist to lead GMP Document Control, Records Management and eQMS oversight. You will ensure regulatory compliance, data integrity, and alignment with company policies across QA, Manufacturing and Regulatory Affairs.

The role focuses on controlled documentation, training, and archival lifecycle, driving improvements and supporting internal and external inspections. A strong background in GMP/QMS is essential.