Change Control & Continuous Improvement Lead

RXinsider LTD.; Columbia (SC); On-site; USD 90,000 - 130,000; Full time

Job summary

RXinsider LTD. seeks a Change Control Continuous Improvement Manager to lead process improvements in change control and document revision within a regulated environment. You will drive KPI development, data analysis, and training to ensure compliant, efficient workflows.

Serving as SME for eQMS (Dot Compliance), you will collaborate with Manufacturing, Engineering, Regulatory, Validation and Quality to optimize workflows and performance.

Qualifications

• Degree in Life Sciences, Pharmacy, Engineering or related field.
• 3–4 years in document control and/or QA in regulated env.
• Working knowledge of cGMP and FDA regulations.
• 3+ years with DMS platforms such as TrackWise or Dot Compliance.
• Experience with batch record lifecycle management.

Responsibilities

• Lead continuous improvement for change management processes.
• Analyze data to identify bottlenecks and compliance risks.
• Develop and monitor KPIs for change control and document revision.
• Collaborate with Manufacturing, Engineering, Regulatory Affairs, Validation, and Quality.
• Provide training on document control and change control processes.

Skills

Continuous Improvement

Change Control

Document Revision

eQMS

Data Analysis

Training Materials

SOP Writing

Project Management

Cross-functional Collaboration

Regulatory Awareness

Education

Bachelor's degree in Life Sciences

Bachelor's degree in Pharmacy/Engineering/Business

Master's degree (preferred)

Tools

TrackWise

TrackWise Digital

Dot Compliance

Veeva Vault

MasterControl

Job description

RXinsider LTD. seeks a Change Control Continuous Improvement Manager to lead process improvements in change control and document revision within a regulated environment. You will drive KPI development, data analysis, and training to ensure compliant, efficient workflows.

Serving as SME for eQMS (Dot Compliance), you will collaborate with Manufacturing, Engineering, Regulatory, Validation and Quality to optimize workflows and performance.