Description

The Quality Manager is responsible for the management of the quality assurance system along with the management of the Certificate of Compliance program, CAPA process, change control, vendor qualification program and company quality KPIs.

The Quality Manager is responsible for setting the overall quality systems and being the voice of the customer to meet their requirements and company internal goals.

The Quality Manager will work cross-functionally with other departments to provide support for Sales to develop new business opportunities, increase quality knowledge via internal and external training and improve product nonconformance communications.

Requirements

• 5+ years of experience in a quality role
• Experience in packaging/manufacturing industry is a plus
• Exposure and experience in GMP and ISO manufacturing environment is a plus
• Knowledge on FDA regulations pertaining to primary packaging of pharmaceuticals
• Demonstrated success in the areas of product defect investigations, corrective actions, and root cause analysis
• Possessing Lean 6 Sigma Black or Green Belt certification
• Training and exposure to statistical quality control and modern quality tools