Quality Compliance Lead | GMP, Audits & QMS

Koch Industries Inc.; Hudson, Menomonie, New Richmond (WI, WI, WI); On-site; USD 70,000 - 100,000; Full time

Job summary

Phillips Medisize, a Molex company, seeks a Quality Compliance Specialist to support the divisional Quality Compliance team and drive regulatory adherence across sites. Onsite role with potential bases in Hudson, New Richmond, or Menomonie, MN, focusing on GMP compliance and quality assurance improvements.

You will manage audits, lead CAPAs, and train colleagues while leveraging data analytics to identify trends and improve processes. Travel 10–20% for audits and inspections is required.

Qualifications

• Bachelor’s degree in quality management, Chemistry, Microbiology, Regulatory Affairs, or related field OR 5+ years of QA experience in a regulated industry.
• Experience in cGMP manufacturing and quality assurance practices.
• Strong understanding of FDA, ISO, and GMP requirements.
• Experience with data analysis and reporting tools (Excel, PowerPoint, Power BI).

Responsibilities

• Ensure compliance with GMP and relevant regulations and standards across multiple sites.
• Lead investigations, CAPAs, and change control processes.
• Act as a subject matter expert on quality topics, advising on policies and compliance decisions.
• Manage internal and external audits, and host regulatory inspections.
• Collaborate with teams to address audit findings and enhance compliance.
• Conduct gap assessments and recommend strategies for regulatory compliance.
• Support and manage Quality Management System (QMS) processes.
• Deliver training programs to enhance compliance with QMS requirements.
• Drive quality improvement projects using data analytics to identify trends.
• Travel 10% - 20% for audits and compliance activities.

Skills

Auditing

Regulatory awareness

Data analysis

Quality systems thinking

Education

Bachelor's degree in quality management or related field

5+ years QA experience in regulated industry

Tools

Excel

PowerPoint

Power BI

Job description

Phillips Medisize, a Molex company, seeks a Quality Compliance Specialist to support the divisional Quality Compliance team and drive regulatory adherence across sites. Onsite role with potential bases in Hudson, New Richmond, or Menomonie, MN, focusing on GMP compliance and quality assurance improvements.

You will manage audits, lead CAPAs, and train colleagues while leveraging data analytics to identify trends and improve processes. Travel 10–20% for audits and inspections is required.