Senior Quality Systems Manager - GMP & ISO 9001

RRD Company; Cudahy (WI); Vor Ort; USD 85.000 - 136.000; Vollzeit

Zusammenfassung

RRD is seeking a Quality Assurance Manager in Wisconsin to oversee and advance the site’s quality systems and standards. You will lead the QMS maintenance and continuous improvement, ensuring compliance with ISO 9001:2008, GMP (21 CFR Part 820), and customer/regulatory requirements.

You will manage internal audits, CAPA processes, and Quality Metrics, while guiding the quality team and collaborating with cross-functional stakeholders to sustain high-quality outputs for regulated products.

Qualifikationen

• 4 year or bachelor’s degree in related field.
• Advanced training or experience in cGMPs and ISO.
• Excellent written and verbal communication skills.

Aufgaben

• Lead and improve the site's QMS and processes.
• Maintain compliance with QMS requirements and regulatory standards.
• Coordinate ISO 9001:2008, GMP (21 CFR Part 820), and audit activities.
• Identify issues, perform root cause analysis, and drive corrective actions.
• Monitor GMP Quality Metrics and report trends.
• Prepare for certification audits and maintain audits schedules.
• Interact with customers on quality responses to RFPs/RFIs.
• Oversee quality department staff and ensure deviation investigations are completed.
• Drive CAPA items to timely completion and closure.
• Support additional quality initiatives as needed.

Kenntnisse

cGMPs

ISO standards

Root cause analysis

Microsoft Office

Leadership

Written and verbal communication

Ausbildung

Bachelor's degree in related field

Tools

Microsoft Office

Jobbeschreibung

RRD is seeking a Quality Assurance Manager in Wisconsin to oversee and advance the site’s quality systems and standards. You will lead the QMS maintenance and continuous improvement, ensuring compliance with ISO 9001:2008, GMP (21 CFR Part 820), and customer/regulatory requirements.

You will manage internal audits, CAPA processes, and Quality Metrics, while guiding the quality team and collaborating with cross-functional stakeholders to sustain high-quality outputs for regulated products.