Manager, Visual Inspection

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

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Manager, Visual Inspection

Professional Lenoir, NC, US

7 days ago Requisition ID: 2061

Position Summary

The Visual Inspection Manager is responsible for leading the development, execution, and continuous improvement of the site’s Visual Inspection Program in support of pharmaceutical manufacturing operations. This role provides technical expertise in inspector qualification, defect standards, particulate control, AQL strategy, reinspection processes, and inspection performance validation to ensure product quality, regulatory compliance, and operational excellence. The position partners cross-functionally with manufacturing, quality, technical, and client-facing teams to identify gaps, drive CAPA, support investigations, lead process improvements, and serve as a subject matter expert during client and regulatory audits.

Job Responsibilities

• Lead the development, review, and continuous improvement of Visual Inspection Program protocols and technical documentation, including:
  • Inspector training and qualification programs
  • Defect test set creation, maintenance, and lifecycle management
  • AQL (Acceptable Quality Level) strategy
  • Reinspection and second-pass inspection processes
• Identify gaps in visual inspection documentation and drive corrective and preventive actions (CAPA) to ensure compliance and operational excellence.
• Lead defect classification, reject trending, and particulate identification initiatives to enhance product quality and process understanding.
• Develop and maintain defect standards, incorporating real production defects into inspection test sets to ensure robustness and realism.
• Lead Probability of Detection (PoD) studies to calibrate and validate defect detection capability and inspection effectiveness.
• Partner cross-functionally to drive process improvements and implement upstream particulate control strategies.
• Serve as Subject Matter Expert (SME) for Visual Inspection during client and regulatory audits, ensuring alignment with FDA, PDA, USP, and industry best practices.
• Maintain and continuously enhance the Visual Inspection Program in accordance with evolving regulatory guidance and standards.
• Provide SME support for manufacturing operations, deviations, and investigations, ensuring thorough root cause analysis and effective resolutions.
• Deliver technical guidance on inspection methods, including validation activities and Manual Visual Inspection (MVI) to Automated Visual Inspection (AVI) performance comparisons.
• Drive project execution across the full lifecycle, including strategic planning, timeline development, and cross-functional resource management.
• Lead and mentor team members, fostering talent development through coaching, knowledge sharing, and performance guidance.
• Proactively coordinate and manage deliverables across departments to ensure alignment, timeliness, and quality outcomes.
• Prioritize and delegate tasks effectively to optimize team productivity and meet organizational goals.
• Demonstrate strong communication, presentation, and influencing skills to engage stakeholders, clients, and internal teams.
• Build and sustain high-impact relationships with clients, stakeholders, and cross-functional partners.
• Perform additional duties as required to support business objectives.

Experience Requirements

• Ability to balance important and competing priorities in a fast-paced work environment
• Good understanding of Pharmaceutical or life sciences manufacturing processes, and cGMP practices with an expertise in Visual Inspection and Particulate Control measures
• Highly organized and possess proven critical thinking skills
• Possess effective communication skills, acute attention to detail and accuracy.
• Ability to self-initiate
• Familiarity with software tools for such as Microsoft Project, Excel, Word, PowerPoint, Smart-Sheet, One-Note

Education Requirements

• >7 years of Pharmaceutical Industry Experience or equivalent combination of education and experience.
• Bachelor's degree in a relevant field (such as Pharmaceutical Sciences, Life-Sciences, Engineering, or Project Management)