Change Management Lead

2 weeks ago


Kankakee, Illinois, United States CSL Behring Full time

This position is accountable for managing and implementing modifications within the Value Stream, overseeing the entire process while collaborating with a network of Subject Matter Experts to ensure that the necessary cGMP documentation is in place to support the change and adheres to the quality system.

KEY RESPONSIBILITIES

+ Accountable for the formulation, initiation, and documentation of changes within the electronic Quality Management System (eQMS) for the designated Value Stream; possessing a solid understanding of Validation and Regulatory strategies to facilitate the change.

+ Works in partnership with Subject Matter Experts to outline a comprehensive change plan, assessing all areas of impact prior to the approval of the change within the eQMS.

+ Collaborates with Quality Delegates in the respective Value Stream to ensure that the change control process is developed correctly and is fully compliant.

+ Manages the change process from inception to completion, ensuring that action owners are held accountable for fulfilling their responsibilities by the established deadlines.

+ Responsible for presenting the thoroughly developed change to the Change Review Board, as necessary, to obtain approval for routing the change for final authorization.

+ Responsible for presenting the fully developed change to the Global Change Panel, if required, ensuring that the meeting minutes from the Global Change Panel meeting are compiled and attached to the relevant record in the eQMS.

+ Assists the team with Corrective and Preventive Actions (CAPAs) and root cause analysis when assigned by management.

+ Promotes a culture of continuous improvement through employee selection, training, and mentoring, while concentrating on operational efficiency and the elimination of non-value-added activities.

QUALIFICATIONS

Education

B.A. or B.S. Degree, preferably in a scientific or technical discipline (e.g., Chemistry, Biology, Engineering, Computer Science).

OR

GED/High School Diploma with a minimum of 8 years of experience in the Pharmaceutical Industry.

Experience

3+ years of experience in Manufacturing.

Extensive technical experience in:

- Change Management

- Change Control

- CAPA

- Root Cause Analysis

Knowledge of cGMPs and FDA guidelines is essential.

Excellent communication skills with the ability to convey information clearly, both verbally and in writing.

Proven ability to manage multiple tasks 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.

Our Benefits

CSL employees working at least 30 hours per week are eligible for benefits effective from day one. We are dedicated to the wellbeing of our employees and their families. CSL provides resources and benefits, ranging from healthcare to financial protection, allowing you to focus on impactful work. Our benefits are designed to meet the needs of our employees at every stage of their lives.

About CSL Behring

CSL Behring is a global leader in the development and delivery of high-quality medicines that treat individuals with rare and serious diseases. Our therapies provide hope for patients in over 100 countries dealing with conditions in immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

Diversity and Inclusion

As a global organization with employees in more than 35 countries, CSL values diversity and inclusion. We are committed to creating a workplace that reflects the world around us.

Equal Opportunity Employment

CSL makes all employment decisions without regard to race, color, religion, national origin, ancestry, age, sex, gender, pregnancy, disability, marital status, sexual orientation, gender identity, genetic information, military status, protected veteran status, or any other classification protected by applicable laws.



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