Quality Leader - ISO 9001 & CGMP, Lab & Compliance

Aurorium; Zeeland (MI); On-site; USD 90,000 - 130,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Life insurance

401(k)

Disability insurance

Flexible spending accounts

Health savings accounts

Paid time off

Paid holidays

Job summary

Aurorium, a global materials innovator, seeks a Quality Manager to lead the on-site QA/QC program, driving ISO 9001 and CGMP compliance. You’ll develop and improve the Quality Management System, lead investigations, and ensure timely product releases and regulatory alignment.

In this role you’ll manage audits, CAPA, and training across the site’s QA teams, collaborating with Regulatory Affairs and contract labs to maintain high quality standards and customer satisfaction.

Qualifications

• BS degree in Chemistry or Engineering; MS preferred.
• 7+ years’ experience in a CGMP environment—Food, API, Excipient or Pharmaceutical manufacturing.
• 3+ years’ experience in a supervisory/lead role.
• Internal auditor training.
• ASQ certification (CQE, CQA or CMQ/OE) preferred.
• Proficiency in ISO 9001 and CGMP; Lean/Six Sigma preferred.
• SAP experience and MS Office suite familiarity.

Responsibilities

• Oversee the development, implementation, review, maintenance, and management of the on-site Quality Management System.
• Approve plant procedures and changes affecting product quality; maintain SOPs and forms in the DMS.
• Collaborate with Regulatory Affairs on regulatory aspects (registration, licensing, DMFs, CEPs, validations).
• Lead Change Management, OOS, Deviation and CAPA programs; manage CGMP compliance activities.
• Coordinate audits (internal, supplier, customer) and provide timely responses and corrective actions.
• Lead investigations of customer complaints and ensure timely updates to leadership.

Skills

Leadership

Quality management

Problem solving

Time management

Training/mentoring

Autonomy

Decision making

Education

BS in Chemistry or Engineering

MS preferred

Tools

SAP

MS Office

DMS (Document Management System)

Job description

Aurorium, a global materials innovator, seeks a Quality Manager to lead the on-site QA/QC program, driving ISO 9001 and CGMP compliance. You’ll develop and improve the Quality Management System, lead investigations, and ensure timely product releases and regulatory alignment.

In this role you’ll manage audits, CAPA, and training across the site’s QA teams, collaborating with Regulatory Affairs and contract labs to maintain high quality standards and customer satisfaction.