About this role
Description
Job Purpose:
The Visual Inspection Program Leader is responsible for the technical leadership, governance, and continuous improvement of the Visual Inspection Program for injectable and ophthalmic pharmaceutical products manufactured in a sterile environment. This role serves as a technical Subject Matter Expert (SME) and program owner, providing strategic direction for manual and automated visual inspection systems, inspector qualification, defect standards and test sets, AQL strategy, Probability of Detection (PoD) studies, defect classification, particulate characterization, inspection validation, and ongoing program performance. This position provides technical leadership across the full lifecycle of Visual Inspection Program initiatives—from strategy and risk assessment through study design, execution, data analysis, implementation, effectiveness monitoring, and continuous improvement—while serving as a key technical representative during customer, regulatory, and quality audits.
Essential Duties and Responsibilities:
• Own and provide technical leadership for the Visual Inspection Program, including program strategy, governance, standards, procedures, protocols, technical reports, and continuous improvement initiatives.
• Develop, review, approve, and maintain technical documentation supporting visual inspection activities, including:
o Inspector training, qualification, and requalification programs
o Defect classification standards and libraries
o Defect test sets and test set lifecycle management
o AQL sampling strategies and acceptance criteria
o Manual Visual Inspection (MVI) strategies
o Automated Visual Inspection (AVI) strategies
o Visual inspection validation and qualification protocols
o Probability of Detection (PoD) study protocols and reports
• Establish scientifically sound and risk-based approaches for assessing inspection capability, defect detectability, inspection effectiveness, and product quality risk.
• Lead defect classification, defect characterization, reject trending, and particulate identification initiatives to improve product and process understanding.
• Develop, qualify, and maintain defect standards that represent actual manufacturing defect populations and appropriately challenge inspection systems.
• Evaluate inspection program performance using statistical and data-driven approaches and translate findings into actionable technical improvements.
• 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.
• 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.
• 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.
• Assist with additional work duties or responsibilities as evident or required.
Requirements
Knowledge & Skills:
• Strong technical knowledge of pharmaceutical visual inspection principles, including Manual Visual Inspection (MVI), Automated Visual Inspection (AVI), defect detection, defect classification, particulate assessment, container/closure defects, and inspection system performance.
• Strong understanding of sterile injectable and/or ophthalmic pharmaceutical manufacturing processes and their relationship to visible particulate, cosmetic defects, container integrity, and other inspection attributes.
• In-depth knowledge of applicable cGMP, GDP, FDA regulations and guidance, USP requirements, PDA technical reports, and relevant industry standards related to visual inspection and sterile pharmaceutical manufacturing.
• Ability to develop scientifically sound protocols, technical reports, acceptance criteria, study designs, and technical justifications.
• Must be able to work individually and on a team.
• Salary range: Based on experience.
Education/Experience:
- Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biology, Engineering, Life Sciences, or a related scientific or technical discipline required.
- Master's degree or advanced technical education preferred.
- 7+ years of progressive experience in pharmaceutical manufacturing, quality, visual inspection, validation, technical operations, or a related discipline, with significant experience in sterile injectable and/or ophthalmic manufacturing.
- Experience leading cross-functional technical projects from strategy and planning through execution, implementation, and effectiveness monitoring.
- Experience supporting regulatory inspections, customer audits, deviations, investigations, CAPA, change controls, and other quality systems activities as a technical SME.
- Experience with statistical analysis, defect/reject trending, data interpretation, and risk-based decision-making preferred.
- Experience with automated inspection technologies, inspection equipment qualification, or MVI/AVI comparability assessments highly preferred.
- Experience working within aseptic processing and sterile manufacturing environments highly preferred.
- Equivalent combination of education, technical expertise, and relevant pharmaceutical experience may be considered where appropriate.
Working Conditions / Physical Requirements:
- Position may require bending, typing climbing, lifting (up to 15lbs.), reaching, vision (20/20 corrected), standing, sitting, walking, and hearing.