Quality Excellence Leader - GMP & Compliance

IKI Manufacturing; Edgerton (WI); On-site; USD 90,000 - 140,000; Full time

Job summary

IKI Manufacturing is seeking a Quality Manager to lead all Quality Systems and initiatives, ensuring regulatory compliance and product integrity. You will supervise Laboratory, QC, and Quality Support staff, driving continuous improvement across manufacturing processes and supplier quality...

Responsibilities include investigations of non-conformances, CAPA development, SOP authoring, and coordinating client audits.

Qualifications

• Bachelor’s degree in Chemistry, Engineering, or related field.
• Minimum of 5 years of progressive experience in a quality leadership role within a manufacturing environment.
• GMP, EPA, and FDA regulations knowledge.

Responsibilities

• Lead Quality Systems and initiatives to ensure product quality and regulatory compliance.
• Direct supervisory responsibility for Laboratory, QC, and Quality Support staff.
• Collaborate with Operations to drive continuous improvement in production quality.
• Lead investigations of non-conformances and implement corrective and preventive actions.
• Develop, update, and enforce SOPs; train quality personnel to IKI QMS.
• Coordinate client quality audits and communicate findings to stakeholders.

Skills

GMP/EPA/FDA regulations

Analytical lab equipment

Microbial testing

Aerosol manufacturing

Communication skills

Organizational skills

Time management

Analytical thinking

Leadership skills

Delegation

MS Office

Education

Bachelor’s degree in Chemistry, Engineering, or related field

Tools

Laboratory instruments

Job description

IKI Manufacturing is seeking a Quality Manager to lead all Quality Systems and initiatives, ensuring regulatory compliance and product integrity. You will supervise Laboratory, QC, and Quality Support staff, driving continuous improvement across manufacturing processes and supplier quality...

Responsibilities include investigations of non-conformances, CAPA development, SOP authoring, and coordinating client audits.