GMP Quality Compliance Lead: Audits & CAPAs (Onsite)

Koch Business Solutions, LP; New Richmond (WI); On-site; USD 70,000 - 110,000; Full time

Benefits offered by this job

Medical insurance

Dental & Vision

Education assistance

Paid time off

Job summary

Phillips Medisize, a Molex company, seeks a Quality Compliance Specialist to strengthen regulatory adherence across sites. This role supports the divisional Quality Compliance team and drives excellence in quality systems and compliance practices.

Onsite role based in Hudson, New Richmond, or Menomonie, with 10–20% travel for audits. You will manage audits, CAPAs, change control, and training, fostering continuous improvement and a culture of quality.

Qualifications

• Bachelor's degree in quality management, Chemistry, Microbiology, Regulatory Affairs, or 5+ years in Quality Assurance in a regulated industry.
• Experience in cGMP manufacturing and quality assurance practices.
• Familiarity with 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

Regulatory affairs

Quality assurance

Auditing

Education

Bachelor's degree in quality management / Chemistry / Microbiology / Regulatory Affairs

Tools

Excel

PowerPoint

Power BI

Job description

Phillips Medisize, a Molex company, seeks a Quality Compliance Specialist to strengthen regulatory adherence across sites. This role supports the divisional Quality Compliance team and drives excellence in quality systems and compliance practices.

Onsite role based in Hudson, New Richmond, or Menomonie, with 10–20% travel for audits. You will manage audits, CAPAs, change control, and training, fostering continuous improvement and a culture of quality.