Quality Assurance Manager — GMP/ISO Excellence

RR Donnelley & Sons; Cudahy (WI); On-site; USD 90,000 - 120,000; Full time

Job summary

RR Donnelley & Sons seeks a Quality Assurance Manager to oversee the site Quality Management System and advance quality standards.

You will lead audits, drive CAPA, and ensure compliance with GMP, ISO 9001 and 21 CFR Part 820 while coordinating with site management.

The role requires 5+ years in QA with at least 2 years in supervision, strong communication, and the ability to prioritize multiple initiatives.

Qualifications

• Bachelor's degree in a related field.
• Minimum 5+ years of QA experience with at least 2 years in supervisory roles.
• Advanced training or experience in cGMPs and ISO requirements.
• Ability to interpret federal regulations and apply to regulated products.
• Strong prioritization and multitasking skills with minimal supervision.
• Proficiency in Microsoft Office Suite.

Responsibilities

• Maintain and continually improve the site QMS and related processes.
• Coordinate ISO 9001:2008 and GMP audits and certification readiness.
• Lead and mentor quality staff and manage deviation investigations and CAPAs.
• Monitor quality metrics and report to Platform Quality Lead.
• Interface with customers on quality responses to RFPs/RFIs.
• Review GMP documents for compliance with SOPs and regulatory requirements.

Skills

Quality Assurance

Regulatory knowledge

Leadership

GMP/cGMPs understanding

Documentation & reporting

Education

Bachelor's Degree in Related Field

Tools

Microsoft Office

Job description

RR Donnelley & Sons seeks a Quality Assurance Manager to oversee the site Quality Management System and advance quality standards.

You will lead audits, drive CAPA, and ensure compliance with GMP, ISO 9001 and 21 CFR Part 820 while coordinating with site management.

The role requires 5+ years in QA with at least 2 years in supervision, strong communication, and the ability to prioritize multiple initiatives.