Quality Systems Manager-Change Control

CSL Behring

Kankakee, IL 60901

Posted 1 month ago

Job Description

CSL Behring in Kankakee, Illinois has grown into a global biotechnology leader driven by that


same promise to save and improve lives. We offer the broadest range of quality plasma-derived and recombinant therapies in our industry. We have recently been awarded **_America’s Best Employer for 2022 by Forbes_** magazine thus offer an exciting opportunity to join CSL as Quality Systems Manager- Change Control


**Quality Systems Manager – Change Control**


This role is responsible for:


+ Site Change Control Process/Quality System owner to ensure compliance with CSL standards and Regulatory guidelines.


+ Manages the following aspects of site change control:


+ Establishes and maintains training


+ Site SOPs and work instructions in relation to Change Control


+ Accountability for Regulatory Inspection, Self-inspection, system improvements, and deviations for the Change Control Quality System.


**This position reports to: Sr. QA Compliance Manager**


Principal Responsibilities:


+ Local system owner for the change control process


+ Translates global requirements from the Global QMS Operations team for change control, to develop all site quality change control system for local use. Includes the 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 the Kankakee site.


+ Responsible for the “Management of Change” processes on site, including EHS, Automation, and other departments, to ensure that various change processes are aligned, and clearly utilized across the site. This separation between quality oversite and execution of change activities is at the cornerstone of the program


+ Must be able to explain practices of change control, best practices and procedures, and influence adoption of behavior by stakeholders and end users of the system.


+ Matrix guidance, support and mentorship to the Quality Delegates within the Value Streams to maintain alignment across the site of the change control system, ensuring the eQMS and process are aligned and utilized consistently across the site and globally. Educates the site on the regulatory and corporate expectations for quality change management.


+ Site Representative to the Global QMS Operations group, carrying all responsibilities as assigned by that team, including, but not limited to, strategy for Global Change Panel meetings.


+ This role is the SME to the QA Value Stream Leads, whom are the responsible QA for change control execution in the value streams. This SME counsels the QA teams in identifying potential change control issues in substance and methodology. This is the accountable role at the site to ensure compliance to the Change Control system.


+ Establishes and facilitates the site Change Control Review board, providing Senior Leadership the change updates for in 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.


+ Completes any other duties/responsibilities assigned by senior management.


**Education:** Bachelor’s degree in relevant discipline (or equivalent)


**Qualifications:**


+ 5+ years’ GMP industry experience, 1 or more years’ experience managing teams directly or in a networked accountability


+ Significant technical expertise in:


+ Change Management


+ Change Control


+ 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.


+ Knowledge of cGMP principles and regulatory requirements


+ Demonstration competency of verbal and written communication


**Competencies:**


**Action Oriented**


Readily takes action on challenges, without unnecessary planning


**Global Perspective**


Looks toward the broadest possible view of an issue or challenge, knows the impact of global change on the organization.


**Customer Focus**


Gains insight into customer needs and identifies opportunities that benefit the customer.


**Change Management:**


Mobilizes others to initiate change; builds group momentum for change; embeds culture of change. Aligns change to enterprise strategies and direction.


**Our Benefits**


We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care (https://www.cslbehring.com/careers/how-we-care-for-you-at-csl) 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 (https://www.cslbehring.com/our-company) .


**We want CSL to reflect the world around us**


As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion (https://www.cslbehring.com/careers/diversity-and-inclusion) at CSL.


**Do work that matters at CSL Behring!**


R-172989

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 (specifically status as a disabled veteran, recently separated veteran, armed forces service medal veteran, or active duty wartime or campaign badge veteran) or other classification protected by applicable US federal, state or local law. CSL complies with all applicable employment laws, including but not limited to Title VII of the Civil Rights Act of 1964, the Americans with Disabilities Act, the Fair Labor Standards Act, and the Immigration Reform and Control Act. https://www.cslbehring.com/careers/eeo-statement



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