QRM (Quality Risk Management) Process Owner

Responsibilities

• QRM (Quality Risk Management) Process Owner 

  Responsibilities 

• Site owner for the Annual Product Quality Review process. Works with Global Quality team to ensure local for APQR is aligned guidelines. 
• Specific responsibilities include development of and delivery of training for the quality system, responsible for the system’s compliance with global standards and local market requirements, and oversight of the execution of the system on site. 
• Site owner for the Risk Register. Works with Global Quality team to ensure local for Risk register is aligned 
• Responsible for the development of and delivery of training for the quality system, for the system’s compliance with global standards and local market requirements, and oversight of the execution of the system on site. 
• Site owner for the Quality Risk Management /process/system. Works with Global Quality team to ensure local for Risk register is aligned Responsible for the development of and delivery of training for the quality system, for the system’s compliance with global standards and local market requirements, and oversight of the execution of the system on site. 
• Establishes processes at the Kankakee site to engage the Quality Value Streams in providing information for the Quality Risk Register, and the Quality Risk Management in discussion. 
• Establishes and facilitates the site APQR, Risk Register, and Quality Risk Management communication, providing Senior Leadership the statuses of each for the facility. 
• Foster a culture of continuous improvement through employee selection, training and mentoring while focusing on operational efficiency and the elimination of “non-value added” activities. 
• Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance. 
• Complies with requirements from CSL Behring’s Safety Program, including Health and Safety mandates and OSHA requirements. 

Education: 

• Bachelor’s degree in relevant discipline (or equivalent) 

Qualifications: 

• 5+ years industry experience  
• Significant technical expertise in Quality Systems 
• Knowledge of cGMP principles and regulatory requirements 
• 1 or more years’ experience managing a team 
• Demonstrated ability to influence decisions, drive continuous improvement, increase value of systems to the business and create an environment of continuous inspection readiness and right-first-time execution. 
• Thinks beyond the system at hand, maintaining an external and strategic focus to drive compliant solutions. 
• Demonstration competency of verbal and written communication 

Our Benefits

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