Quality Leader - ISO 9001/GMP & CGMP Expert

Vertellus; Zeeland (MI); On-site; USD 110,000 - 150,000; Full time

Benefits offered by this job

Medical

Dental

Vision

401(k)

Life Insurance

Disability Insurance

PTO

Paid Holidays

Job summary

Aurorium is seeking a Quality Manager to lead QA and QC activities at the Zeeland site. You will develop and maintain a robust quality management system aligned with ISO 9001 and GMP, ensuring product quality meets customer and regulatory expectations.

You will oversee audits, CAPA, training, and regulatory compliance, while managing the Quality department budget and coordinating with Regulatory Affairs and suppliers to sustain continuous improvement and product integrity.

Qualifications

• BS degree in Chemistry or Engineering; MS preferred.
• ASQ certification (CQE, CQA or CMQ/OE) preferred.
• 7+ years in a CGMP environment in manufacturing.
• 3+ years in a supervisory/lead role.

Responsibilities

• Oversee development, implementation, and maintenance of the on-site Quality Management System.
• Approve plant procedures and changes affecting product quality.
• Coordinate regulatory activities with Regulatory Affairs including registrations and GMPs.
• Lead investigations of quality issues and implement CAPA programs.
• Manage audits, supplier quality, and contract laboratories.
• Train and mentor QA/QC staff and ensure CGMP compliance.

Skills

Quality management

Auditing

Regulatory compliance

Leadership

Problem solving

Lean Six Sigma

MS Office

Education

BS in Chemistry or Engineering

MS preferred

ASQ certs preferred

Tools

SAP

MS Office

Job description

Aurorium is seeking a Quality Manager to lead QA and QC activities at the Zeeland site. You will develop and maintain a robust quality management system aligned with ISO 9001 and GMP, ensuring product quality meets customer and regulatory expectations.

You will oversee audits, CAPA, training, and regulatory compliance, while managing the Quality department budget and coordinating with Regulatory Affairs and suppliers to sustain continuous improvement and product integrity.