Quality Assurance Manager — GMP/ISO Compliance Leader

RRD; Cudahy (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

RRD is seeking a Quality Assurance Manager to oversee and advance our quality systems and standards! The role focuses on implementing and maintaining a robust QMS, metrics, and continuous improvement across the site.

The successful candidate will lead the quality team and drive CAPA, audits, and regulatory alignment to ensure compliant, quality products. Strong collaboration with management and operations is essential, with emphasis on customer-facing quality responses and adherence to ISO 9001

Qualifications

• Minimum 4-year Bachelor's Degree in a related field.
• 5+ years related work experience with at least 2 years supervisory experience.
• Advanced training or experience in cGMPs and ISO requirements.

Responsibilities

• Lead and improve the site Quality Management System and Quality Metrics.
• Coordinate annual certification audits and GMP/regulatory compliance.
• Perform root cause analysis and drive CAPA closure.
• Monitor QMS processes and report metrics to leadership.
• Support customer inquiries and RFP/RFI responses related to quality.
• Oversee deviation investigations and document findings.
• Lead quality department personnel and provide direction.

Skills

Quality Mgmt

GxP Knowledge

Leadership

Auditing

Regulatory Knowledge

Education

Bachelor's Degree in Related Field

Tools

MS Office

Job description

RRD is seeking a Quality Assurance Manager to oversee and advance our quality systems and standards! The role focuses on implementing and maintaining a robust QMS, metrics, and continuous improvement across the site.

The successful candidate will lead the quality team and drive CAPA, audits, and regulatory alignment to ensure compliant, quality products. Strong collaboration with management and operations is essential, with emphasis on customer-facing quality responses and adherence to ISO 9001