Job Description

GENERAL SUMMARY This position is responsible for analyzing quality performance of assigned business area. * Serves as the subject matter expert for US CSL Plasma quality systems for document and change management * Assists in the design, implementation, and delivery of quality systems and processes related to change and document management * Responsible for reviewing and monitoring quality metrics and reports for trends and opportunities for improvements RESPONSIBILITIES * Recognized as a subject matter expert for CSL Plasma quality systems and processes. Explains to business stakeholders and end users the facts, policies, and practices related to document control and change management. * Ensure compliance to and successful use of the Quality Systems for Change Management. Conduct regular review of quality performance to ensure stable, high levels of compliance performance. Provide routine metric and KPI data for the management review quality systems metrics. * Manage assigned projects effectively with an emphasis on multi-tasking and the ability to meet deadlines with quality results. May lead or participate in cross-functional teams to meet project and other deadlines. * Supports evidence-based decision making and process improvement through data analysis. Evaluate areas for potential Process Improvements and implement strategies through project management and participation in key strategic projects. Analyze quality indicators and tack for trends against current standards for opportunities to improve. Coordinate and work closely with team members to identify, vet and implement best practices. * Monitor and analyze performance of quality systems and processes related to document and change management. Analyzes key performance metrics with dashboards for management use. Analyze data within defined criteria to assess impact or scope of notifications. Support quality oversight forums for change management. Prepare regular KPI reviews and provide surveillance metrics analysis to aid the remediation of identified issues and opportunities. Deliver trending data reports to assist in business decisions. Collaborate with cross-functional departments to optimize reporting capabilities. * Assists with the design, implementation and delivery of CSL Plasma programs through application of specialized knowledge and skills. * Monitor and maintain competency with the relevant quality systems, specifically DocNet and TrackWise that support plasma change processes. * Maintain a thorough understanding of the relevant regulations and guidelines, to include but not limited to FDA Good Manufacturing Practices, CSL corporation policies and procedures, GHA/EMA, and other applicable standards, such as ISO Quality Management Standards. * Establishes and maintains a good rapport with all functional groups and team members. Quickly engages with individuals involved in problems who need facilitation through to a successful resolution. Enables them to help themselves in future challenges through use of a disciplined approach to troubleshooting and documentation of steps taken. * Perform other duties as assigned to support business needs. Promotes safety in all aspects of the position. JOB SPECIFICATIONS Education * Requires a Bachelor's degree preferably in Business, Biology or related Health/Science field or equivalent combination of education, training and experience, minimum 4 years preferred Experience * Minimum 3 years' experience successfully serving in a Quality systems role preferable within an FDA or EMA, regulated industry experience required * Experience in change and document management within a regulated industry * Recognized individual contributor with technical expertise in quality systems * Develops, with all functional groups, stakeholder relationships with successful outcomes * Strong written and verbal communication, interpersonal and presentation skills * Excellent problem solving, decision-making, and system thinking skills * Strong ability to identify, monitor, and analyze process and/or system performance * Ability to learn new processes and quickly engage in assignments * Exercise good judgment to refer decisions to management when decisions fall out of the realm of established guidelines Company Description Supported by parent company CSL Behring, the global leader in plasma protein biotherapeutics, CSL Plasma has more than 300 plasma collection centers globally. CSL Plasma also has a state-of-the-art testing laboratory that features some of the most advanced technology, instrumentation and automation in the field; two logistics centers, one in Dallas and one in Indianapolis. Our corporate headquarters is in Boca Raton, Florida. Our U.S. plasma collection centers are committed to the highest standards of quality and safety. When you donate, you give a valuable gift to those who require plasma-derived therapies to live healthier lives. The CSL Group has a combined heritage of outstanding contribution to medicine

Company Description

Supported by parent company CSL Behring, the global leader in plasma protein biotherapeutics, CSL Plasma has more than 300 plasma collection centers globally. CSL Plasma also has a state-of-the-art testing laboratory that features some of the most advanced technology, instrumentation and automation in the field; two logistics centers, one in Dallas and one in Indianapolis. Our corporate headquarters is in Boca Raton, Florida. \r\n\r\nOur U.S. plasma collection centers are committed to the highest standards of quality and safety. When you donate, you give a valuable gift to those who require plasma-derived therapies to live healthier lives.\r\n\r\nThe CSL Group has a combined heritage of outstanding contribution to medicine and human health with more than 100 years’ experience in the development and manufacture of vaccines and plasma protein biotherapies. \r\n\r\nWith major facilities in Australia, Germany, Switzerland and the US, CSL has over 30,000 employees working in 100 countries.