Quality Delegate

Position Purpose: 

This role is responsible for:

• The quality oversight for changes within the Value Stream, providing the review and approval of change controls, release to operations, and the closure.

This role will partner closely with the Quality Systems Manager – Change Control and other Quality Delegates to continuously improve and standardize the change control process across the site.

Principal Accountabilities: 

• Responsible for the quality oversight to all changes within respective Value Streams, ensuring change is fully developed and documented clearly, with appropriate actions and supporting documentation in place to support the change; Understanding Validation and Regulatory strategies in place to support the change.

• Responsible for reviewing document changes that are within scope of change controls, ensuring documentation from both eQMS are accurate and complete; Assists with the determination if document changes require a change control or just document only changes.

• Collaborate with Change Owners within Value Streams, as well as other areas as necessary, to assist with development of change controls.

• Collaborates with the Global QMS Operations team to schedule changes to be presented at the Global Change Panel meetings, as necessary.

• Assists QA Value Stream Lead in identifying potential change control issues with process/system, and communicating with Compliance.

• Participates in site Change Review Board and the Value Stream Change Review Board for respective Value Stream.

• Responsible for reviewing MES changes to eMBRs as part of the change control process.

• 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:

• Undergraduate degree in relevant discipline (or equivalent)

Related Experience:

• 2 years or more years industry experience
• Significant technical expertise in:
  • Change Management
  • Change Control

• Knowledge of cGMPs and FDA guidelines required
• Demonstration competency of verbal and written communication

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.

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 organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at CSL.