About the job
The Quality Assurance Manager will be responsible for overseeing the effective implementation, ongoing maintenance, and continuous enhancement of the site Quality Management System (QMS) and Quality Metrics performance. This role entails collaborating with site management and personnel to plan, develop, implement, and continually refine site-relevant QMS requirements, ensuring compliance with customer, regulatory, and RR Donnelley QMS standards.
*MUST HAVE: Experience in a printing company; familiarity with operating procedures related to printing regulated products and quality concerns is essential.*
Key Responsibilities:
- Provide leadership and support in maintaining and improving the site Quality Management System (QMS) and processes, including food safety and Medical Device/Pharma GMPs as required.
- Ensure compliance of the site QMS with RRD QMS requirements, including Quality Task Tracker and Quality Metrics reporting.
- Coordinate and prepare for annual certification compliance audits for relevant Quality System requirements like ISO 9001:2008 and GMP (21 CFR Part 820).
- Communicate significant quality issues to site management and facilitate root cause analysis and corrective/preventive actions to mitigate errors.
- Monitor trends in QMS processes, including GMP Quality Metrics.
- Evaluate site QMS process effectiveness through internal audits and analysis of Quality Metrics data.
- Collect and report quality task tracker and quality metrics data monthly to the Platform Quality Lead.
- Engage with customers to assist with quality-related responses to RFPs/RFIs.
- Review GMP documents for compliance with company SOPs, quality systems, and regulatory standards.
- Lead and manage internal process verification audits throughout the year.
- Ensure all deviation investigations are conducted and documented appropriately.
- Drive timely completion of CAPA items.
- Participate in additional activities as deemed appropriate.