Quality Operations Lead, Focus Factory

PVH (Tommy Hilfiger/Calvin Klein); Bloomington (IN); On-site; USD 120,000 - 180,000; Full time

Job summary

Simtra BioPharma Solutions in Bloomington, IN is seeking an Associate Director of Quality Operations. The role oversees end-to-end quality for the Focus Factory and reports to the Quality Director, ensuring cGMP compliance, adherence to site procedures, and client commitments across filling, finishing, labeling, packaging, and testing.

The position requires strategic and hands-on leadership to maintain quality, regulatory readiness, and continuous improvement.

Responsibilities

• End-to-end Quality Operations oversight for the Focus Factory.
• Ensure operations comply with cGMP, procedures, and client commitments.
• Provide strategic and day-to-day leadership across Filling, Finishing, Inspection, Labeling, Packaging, and related QC activities.
• Lead CAPA, deviation, and batch disposition processes; support inspections.

Job description

Simtra BioPharma Solutions in Bloomington, IN is seeking an Associate Director of Quality Operations. The role oversees end-to-end quality for the Focus Factory and reports to the Quality Director, ensuring cGMP compliance, adherence to site procedures, and client commitments across filling, finishing, labeling, packaging, and testing.

The position requires strategic and hands-on leadership to maintain quality, regulatory readiness, and continuous improvement.