QRM (Quality Risk Management) Process Owner
- CSL Behring
- Kankakee, Illinois
- Start date
- Feb 3, 2023
- Engineering, Manufacturing & Production, Process
- Required Education
- Bachelors Degree
- Position Type
- Full time
- BioMidwest, Best Places to Work
QRM (Quality Risk Management) Process Owner
- 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.
- Bachelor’s degree in relevant discipline (or equivalent)
- 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
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.
We want CSL to reflect the world around us
As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.
Do work that matters at CSL Behring!
As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research.
CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential.
CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.
CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries.
For more information visit www.cslbehring.com. Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!
Stock Symbol: CSL
Stock Exchange: Australian Securities Exchange
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