- CSL Behring
- Kankakee, Illinois
- Start date
- Feb 2, 2023
- Information Technology, Project/Program Management
- Required Education
- Bachelors Degree
- Position Type
- Full time
- BioMidwest, Best Places to Work
This role is responsible for:
Responsible for owning and executing changes within the Value Streams, from beginning to end, collaborating with a network of Subject Matter Experts, to ensure the cGMP documentation exists to support the change, and follows the quality system.
This role will partner closely with the Quality Delegate in the Value Stream to build robust changes, identifying impacted areas to assess the change.
Responsible for the development, initiation, and documentation of changes within the eQMS, for the respective Value Stream; Understanding Validation and Regulatory strategies in place to support the change.
Collaborates with the network of Subject Matter Experts to define a full developed change plan, understand all areas of impact prior to approval of the change within the eQMS.
Collaborates with Quality Delegates within the respective Value Stream, to ensure the change control is developed appropriately and fully compliant.
Oversees the change from beginning to end, holding the action owners accountable for completing the related actions by due date.
Responsible for presenting the fully developed change to the Kankakee Change Review Board, if deemed necessary, to gain go ahead for routing change for approval.
Responsible for presenting the fully developed change to the Global Change Panel, if deemed necessary, ensuring the meeting minutes from the Global Change Panel meeting are compiled and attached to the associated record in the eQMS.
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.
Completes any other duties/responsibilities assigned by senior management.
Undergraduate degree in relevant discipline (or equivalent)
3+ years or more industry experience
Significant technical expertise in Change Management & Change Control
Knowledge of cGMPs and FDA guidelines required
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
1020 First Avenue
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