This role is 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 and Change Control.
- Knowledge of cGMPs and FDA guidelines required
- Demonstration competency of verbal and written communication
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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!