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Quality Systems Manager-Change Control

Employer
CSL Behring
Location
Kankakee, Illinois
Start date
Jul 29, 2022

View more

Discipline
Engineering, Manufacturing & Production, Process
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
BioMidwest

Job Details

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.

About Us

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 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!

Company

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

Company info
Phone
610-878-4000
Location
1020 First Avenue
King of Prussia
Pennsylvania
19406
United States

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