Change Control & Process Improvement Lead

Nephron Pharmaceuticals; West Columbia (SC); On-site; USD 95,000 - 125,000; Full time

Job summary

Nephron Pharmaceuticals is seeking a Change Control Continuous Improvement Manager to lead process improvements across change control and document revision functions. The role will optimize eQMS performance (e.g., Dot Compliance) and act as SME for document lifecycle management.

The candidate will analyze data, track KPIs, and drive training to ensure compliance with cGMP and FDA regulations while collaborating with Manufacturing, Regulatory Affairs, Validation, and Quality teams.

Qualifications

• Experience in document management and change control within regulated environments (pharmaceutical/biotech/medical device).
• Knowledge of cGMP, FDA regulations, and data integrity principles.
• Experience with eQMS platforms and document lifecycle management.

Responsibilities

• Lead continuous improvement for change management processes from initiation to closure.
• Analyze data to identify bottlenecks, delays, and compliance risks.
• Establish and monitor KPIs for change control and document revision cycle time and accuracy.
• Collaborate with cross‑functional stakeholders to ensure consistent change control application.
• Conduct root cause analysis and implement corrective improvements.
• Develop and deliver training on document and change control processes.

Skills

Continuous improvement

Change control

Document revision

Data analysis

Training materials

Cross-functional collaboration

Quality systems

Education

Associate or Bachelor’s degree in Business Administration, Life Sciences, or a related field

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

Tools

TrackWise

TrackWise Digital

Dot Compliance

Veeva Vault

MasterControl

Microsoft Office

Job description

Nephron Pharmaceuticals is seeking a Change Control Continuous Improvement Manager to lead process improvements across change control and document revision functions. The role will optimize eQMS performance (e.g., Dot Compliance) and act as SME for document lifecycle management.

The candidate will analyze data, track KPIs, and drive training to ensure compliance with cGMP and FDA regulations while collaborating with Manufacturing, Regulatory Affairs, Validation, and Quality teams.