Manager, Inspection Programs

Kindeva Drug Delivery • St. Louis, MO

3d

About The Position

The Inspection Program Manager serves as the site Subject Matter Expert (SME) for Automated Visual Inspection (AVI) and Manual Visual Inspection (MVI) at Kindeva’s St. Louis operations. This role provides technical leadership, governance, and oversight of inspection systems, inspection qualification programs, and defect detection strategies for commercial and military products. The Inspection Manager is accountable for inspection programs, including Limit of Detection (LOD), Probability of Detection (POD), KNAPP studies, Qualification Kits, Time Studies, Test Method Validation (TMV), and Defect Reference Manuals. The role ensures inspection processes are compliant with cGMP expectations, inspection-ready for regulatory agencies, and continuously improving. This position provides direct functional oversight of Inspection Trainers and Visual Inspection Qualification Program, ensuring standardized execution, capability development, and sustained inspection performance across the site.

Requirements

• Bachelor’s degree (or higher) in Engineering, Life Sciences, or a related technical discipline
• 5+ years of pharmaceutical manufacturing experience with visual inspection preferred
• Demonstrated SME experience in AVI and/or MVI systems
• Direct hands‑on experience in TMV, LOD, POD, KNAPP studies, and inspection qualification programs supporting device acceptance activities in accordance with applicable 21 CFR 820 requirements for combination products
• Experience supporting regulatory inspections as a technical SME
• Strong understanding of defect classification and inspection risk
• Ability to statistically evaluate inspection effectiveness and variability
• Proven ability to lead without direct authority and influence cross-functional teams
• Excellent written and verbal technical communication skills

Nice To Haves

• Six Sigma or Lean certification preferred

Responsibilities

• AVI / MVI Technical SME & Program Ownership: Subject matter expert for AVI and MVI inspection strategy, standards, and defect detection philosophy. Own and govern inspection methodologies including LOD, POD, KNAPP studies, TMV, and Time Studies. Establish and maintain Defect Reference Manuals aligned to product, component, and defect risk. Define acceptance criteria, challenge strategies, and qualification requirements for inspection systems. Ensure scientific justification and regulatory defensibility of inspection programs.
• Inspection Qualification & Qualification Kits: Own the design, qualification, maintenance, and governance of Inspection Qualification Kits for all inspection processes. Ensure kits effectively challenge inspectors and equipment across defect types and severities. Partner with Quality, Validation, and Product Technology to ensure inspection kits support TMV and continued process verification. Periodically assess kit effectiveness and update based on performance data and regulatory expectations in accordance with cGMP practices, and CFR21 Part 11.
• Regulatory Inspection Readiness & Compliance: Supports AVI/MVI during regulatory inspections and audits. Ensure inspection programs align with cGMP, internal quality systems, and global regulatory expectations. Author, review, and approve inspection-related SOPs, protocols, and reports.
• Oversight of Trainers and Visual Inspection Qualification Program: Ensure training curricula, qualification methods, and requalification cycles are technically sound and standardized. Coach Leads and Trainers on defect recognition, inspection technique, and performance. Drive consistency in inspection execution across shifts, lines, and products.
• Performance Monitoring & Continuous Improvement: Accountable for maintaining inspection performance with defined thresholds for: Defect escape trends, Inspector performance variability. Lead data-driven improvements to inspection methods, equipment settings, and training approaches. Apply Lean / Six Sigma tools to reduce variation and improve inspection reliability and efficiency.
• Cross‑Functional Leadership & Technical Development: Collaborate with Operations, Engineering, Validation, Quality, and Operational Excellence teams. Support new product introductions, equipment upgrades, and inspection technology changes. Mentor and develop junior technical colleagues and future inspection SMEs. Deliver clear technical communication and leadership-level updates on inspection strategy and risk.

What This Job Offers

• Job Type: Full-time
• Career Level: Manager