Quality Change Control Lead - GMP Compliance

Experis; Wilson (NC); On-site; USD 83,000 - 90,000; Full time

Benefits offered by this job

Medical and Prescription Drug Plans

Dental Plan

Vision Plan

Health Savings Account

Health Flexible Spending Account

Dependent Care Flexible Spending Act

Job summary

Experis in Wilson, NC is seeking a Quality Specialist, Change Control Management to join the QA department and lead change control activities across GMP systems. You will review records, assess risks, and ensure timely closure of changes to protect product quality and patient safety.

The role requires a solid QA background in GMP environments, experience with change controls, and familiarity with Veeva Vault or TrackWise. A proactive, detail-oriented professional will thrive here.

Qualifications

• Bachelor's degree in a related scientific discipline.
• 3–5 years QA experience in a GMP environment.
• 2–3 years of experience managing pharmaceutical change controls.
• Familiarity with Veeva Vault, TrackWise or similar platforms.
• Strong knowledge of cGMP, ICH guidelines and data integrity.

Responsibilities

• Lead and coordinate change control activities throughout the change lifecycle.
• Review, assess, and process change control records for GMP systems, facilities, equipment, and documentation.
• Facilitate impact and risk assessments to evaluate effects on product quality, regulatory filings, and patient safety.
• Ensure timely implementation and closure of change controls, escalating issues as needed.
• Support inspection readiness activities related to change management and regulatory compliance.

Skills

Quality Assurance

Change control

GMP knowledge

ICH guidelines

Data integrity

Education

Bachelor's degree in Chemistry, Biology, Microbiology, Pharmaceutical Sciences, Engineering, or related

Tools

Veeva Vault

TrackWise

Job description

Experis in Wilson, NC is seeking a Quality Specialist, Change Control Management to join the QA department and lead change control activities across GMP systems. You will review records, assess risks, and ensure timely closure of changes to protect product quality and patient safety.

The role requires a solid QA background in GMP environments, experience with change controls, and familiarity with Veeva Vault or TrackWise. A proactive, detail-oriented professional will thrive here.