Head of Visual Inspection & Packaging Operations

incog; Fishers (IN); On-site; USD 110,000 - 160,000; Full time

Job summary

INCOG BioPharma is seeking a seasoned leader to head the visual inspection and packaging of sterile drug products. The Manager will provide strategic direction, operational excellence, and regulatory alignment across 24/5 inspection operations, overseeing three shifts of Inspection Supervisors and their teams.

The role emphasizes continuous improvement, talent development, and serving as the primary liaison between inspection operations and senior leadership, with a focus on cGMP compliance and

Qualifications

• Extensive leadership and program-management capability for inspection/science operations.
• Regulatory compliance knowledge across cGMP, FDA/EMA requirements.
• Cross-functional leadership across shifts, QA, Regulatory, and manufacturing.

Responsibilities

• Develop and execute a strategic vision for the inspection department across 24/5 operations.
• Oversee three shifts of Inspection Supervisors and their teams; ensure scheduling and resource allocation.
• Drive continuous improvement, KPI tracking, and quality metrics for inspection operations.
• Lead deviation investigations, CAPA initiatives, and risk assessments for inspection processes.

Job description

INCOG BioPharma is seeking a seasoned leader to head the visual inspection and packaging of sterile drug products. The Manager will provide strategic direction, operational excellence, and regulatory alignment across 24/5 inspection operations, overseeing three shifts of Inspection Supervisors and their teams.

The role emphasizes continuous improvement, talent development, and serving as the primary liaison between inspection operations and senior leadership, with a focus on cGMP compliance and