Change Owner
This role is responsible for owning and executing changes within the Value Stream, 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.
RESPONSIBILITIES
- 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.
- Responsible to support the team with CAPAs and root cause analysis, when assigned by management.
- 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.
QUALIFICATIONS
Education
B.A or B.S Degree preferably in the scientific or technical field. (e.g., Chemistry, Biology, Engineering, Computer Science)
OR
GED/High School Diploma with a minimum of 8 years of Pharmaceutical Industry experience
Experience
3+ years of Manufacturing experience
Significant technical experience in:
Change Management
Change Control
CAPA
Root Cause Analysis
Knowledge of cGMPs and FDA guidelines required
Strong communication skills – ability to clearly communicate, both verbally and in writing
Demonstrated ability to multi-task while maintaining efficiency within processes and project timelines.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.
Please take the time to review our benefits site to see what’s available to you as a CSL employee.
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.
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.
