Visual Inspection Program Lead

Exela Pharma Sciences LLC; Lenoir (NC); On-site; USD 110,000 - 150,000; Full time

Job summary

Exela Pharma Sciences LLC is seeking a Manager, Visual Inspection in Lenoir, NC. Lead the Visual Inspection Program, drive CAPA, and coordinate cross-functional teams to ensure product quality and regulatory compliance. Requires 7+ years in pharma with expertise in AQL, PoD, defect standards, and client audits.

The role involves oversight of training, documentation, and continuous improvement of inspection processes, aligning with FDA, PDA, USP guidelines and industry best practices.

Qualifications

• Bachelor's degree in a relevant field and 7+ years in pharma/biotech environments.
• Experience with visual inspection, particulate control, and QC systems.
• Track record in CAPA, deviation handling, and regulatory audits.

Responsibilities

• Lead development and improvement of Visual Inspection Program protocols and documentation.
• Identify gaps and drive CAPA to ensure compliance and excellence.
• Lead defect classification, reject trending, and particulate ID initiatives.
• Develop and maintain defect standards with real production defects.
• Lead PoD studies to calibrate detection capability and inspection effectiveness.
• Partner cross-functionally to drive process improvements and upstream controls.
• Serve as SME during client and regulatory audits (FDA, PDA, USP).
• Maintain VI Program per evolving regulatory guidance.
• Provide SME support for deviations and investigations with root-cause analysis.
• Advise on inspection methods, including MVI vs AVI performance.
• Drive project execution across lifecycle with planning and resources.
• Mentor team members and foster talent development.
• Coordinate and manage deliverables across departments; prioritize tasks.

Skills

Visual Inspection

CAPA

AQL Strategy

Regulatory Audits

Project Management

Cross-functional Collaboration

Defect Analysis

Quality Systems

Education

Bachelor's degree in Pharmaceutical Sciences / Life Sciences / Engineering

Tools

Microsoft Project

Excel

Word

PowerPoint

Smartsheet

OneNote

Job description

Exela Pharma Sciences LLC is seeking a Manager, Visual Inspection in Lenoir, NC. Lead the Visual Inspection Program, drive CAPA, and coordinate cross-functional teams to ensure product quality and regulatory compliance. Requires 7+ years in pharma with expertise in AQL, PoD, defect standards, and client audits.

The role involves oversight of training, documentation, and continuous improvement of inspection processes, aligning with FDA, PDA, USP guidelines and industry best practices.