Continuous Improvement Lead, Change Control & eQMS

Socket.dev; West Columbia (SC); On-site; USD 110,000 - 160,000; Full time

Job summary

Socket.dev is seeking a Change Control Continuous Improvement Manager to lead process improvements in change control and document revision within a regulated environment. You will serve as an SME for eQMS and drive data-driven enhancements across departments, including Manufacturing, Engineering, and Regulatory Affairs.

Responsibilities include developing training materials, monitoring KPIs, and collaborating on system improvements to ensure audit readiness and compliance.

Qualifications

• Associate or Bachelor's degree in Life Sciences or related field.
• 3–4 years of experience in document control and/or Quality Assurance in a regulated environment.
• Working knowledge of cGMP, FDA regulations, and data integrity principles.
• Experience with eQMS platforms (TrackWise, Dot Compliance, etc.).
• Proficiency with Microsoft Office and Adobe Acrobat.

Responsibilities

• Lead continuous improvement for change management processes.
• Analyze data to identify bottlenecks and risks.
• Establish KPIs for cycle times and closure rates.
• Provide training and mentoring on document and change control.
• Collaborate with cross-functional stakeholders to ensure proper application.

Skills

Continuous Improvement

Change Control

Data Analysis

Project Management

Documentation

Quality Systems

Education

Bachelor's degree in Life Sciences, Pharmacy, Engineering, or related field

Tools

eQMS Dot Compliance

TrackWise

TrackWise Digital

Veeva Vault

MasterControl

Job description

Socket.dev is seeking a Change Control Continuous Improvement Manager to lead process improvements in change control and document revision within a regulated environment. You will serve as an SME for eQMS and drive data-driven enhancements across departments, including Manufacturing, Engineering, and Regulatory Affairs.

Responsibilities include developing training materials, monitoring KPIs, and collaborating on system improvements to ensure audit readiness and compliance.