Quality Compliance Lead – GMP, Audits & QMS

Phillips Medisize; Hudson (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

Phillips Medisize, a Molex company, is seeking a Quality Compliance Specialist to bolster regulatory and quality standards across all sites. The role focuses on audits, QMS management, and continuous improvement within a dynamic environment.

Based onsite in Wisconsin (Hudson area options), you will lead investigations, CAPAs, change control, and training, while traveling 10–20% for audits and inspections. Strong FDA/ISO knowledge and data analytics are essential.

Qualifications

• Bachelor’s degree in quality management, Chemistry, Microbiology, Regulatory Affairs, or related field.
• Alternatively 5+ years of experience in Quality Assurance within a regulated industry.
• Experience in cGMP manufacturing and QA 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 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

Quality Assurance

Regulatory Compliance

Data Analysis

Education

Bachelor’s degree in quality management, Chemistry, Microbiology, Regulatory Affairs, or related field

Tools

Excel

PowerPoint

Power BI

Job description

Phillips Medisize, a Molex company, is seeking a Quality Compliance Specialist to bolster regulatory and quality standards across all sites. The role focuses on audits, QMS management, and continuous improvement within a dynamic environment.

Based onsite in Wisconsin (Hudson area options), you will lead investigations, CAPAs, change control, and training, while traveling 10–20% for audits and inspections. Strong FDA/ISO knowledge and data analytics are essential.