Manager Quality Assurance at RR Donnelley

The Quality Manager will oversee the implementation maintenance and continuous improvement of the site Quality Management System and Quality Metrics performance. Works with site management and personnel to plan develop implement and continually improve site relevant QMS requirements and to ensure sustainable compliance to customer regulatory and RR Donnelley QMS requirements.Responsibilities Provides ongoing leadership and support in maintaining and continually improving of site Quality Management System (QMS) and processes inclusive of food safety / contact & Medical Device / Pharma GMPs as required.Ensures that site QMS is in compliance with RRD QMS requirements including Quality Task Tracker and Quality Metrics reporting.Coordinates activities to maintain relevant Quality System requirements such as ISO 9001:2008 GMP (21 CFR Part 820) etc. including preparing for and scheduling annual certification compliance audits.Informs site Management of significant or potentially significant quality issues and facilitates effective root cause analysis and corrective/preventive actions to reduce or eliminate errors.Monitors and measures trends in QMS processes including GMP Quality Metrics.Evaluates the effectiveness of relevant site QMS processes (such as ISO 9001:2008 GMP (21 CFR Part 820)) through internal audits and the evaluation of site Quality Metrics data.Collects and submits quality task tracker and quality metrics data for the site on a monthly basis and issues a report to the Platform Quality LeadInteracts with customers and assists with quality related responses to RFPs/RFIs for the site.Reviews relevant GMP documents for compliance to company SOPs quality systems and regulatory requirements.Leads and manages ongoing internal process verification audits throughout year.Provides leadership and direction to quality department employees.Ensures all deviation investigations are appropriately investigated and recorded.Drives CAPA items to complete and timely completion.Participates in other activities as deemed appropriate.Qualifications : EducationMinimum: 4 Year / Bachelors Degree in Related FieldPreferred: Graduate Degree in Related Field  Years of ExperienceMinimum 5 years related work experience including a minimum of 2 years of supervisory experience. Skills and CertificationsAdvanced training or experience in cGMPs and ISO required.Ability to understand and interpret federal regulations and company operating procedures as they apply to printing regulated product and quality issue..Must be able to prioritize and multi-task with minimal supervision.Knowledge of PC systems and Microsoft Office Suite (Word Excel) required.Excellent written and verbal communication skills.Additional Information : The national pay range for this role is $84100 to $134600/ year. The pay range may be slightly lower or higher based on the geographic location of the hired employee. The actual pay offered may vary based upon but not limited to: education skills experience proficiency performance shift and addition to base salary depending on the role the total compensation package may also include participation in a bonus commission or incentive program. RRD offers benefits including medical dental and vision coverage paid time off disability insurance 401(k) with match life insurance and other voluntary supplemental insurance coverages plus tuition assistance maternity leave adoption assistance and employer/partner discounts.All employment offers are contingent upon the successful completion of both a pre-employment background and drug screen.RRD is an Equal Opportunity Employer including disability/veteransRemote Work : NoEmployment Type : Full-time Key Skills Quality Assurance,FDA Regulations,Food Industry,Food Safety Experience,ISO 9001,Quality Systems,Food Processing,Quality Control,Quality Management,QA/QC,Selenium,HACCP Experience: years Vacancy: 1