Manager, Global Quality Engineering

**Your Role**

The Manager, Global Quality Engineering is responsible for quality oversight of GMP capital projects at CSL Behring Broadmeadows. This includes review and approval of all Technology Transfer, QbD, Commissioning and Qualification, Method transfer and validation, process and cleaning validation, CPV, stability and supporting the engineering vendor qualification and quality stage gate process.

You will be the Quality partner to the teams within of Process Engineering and Project Delivery and work closely with members of Global Engineering. In this role you will work closely with your peers in Quality Engineering, Site QA as well as QA-Sterility Assurance and ensure that the same principles and systems are applied across all CSL Behring manufacturing sites.

**This role is a fixed term contract until December 2025.**

**Your Responsibilities**

Reporting to the Associate Director Global Quality Engineering Lead you will ensure GMP-compliant planning and implementation of projects. This will see you:

- Perform QA activities, including issue and risk management capital projects
- Provide a consistent quality approach to utilities, production facilities, equipment, and cleanrooms, with attention to process design
- Ensure GMP compliant execution of project activities in accordance with approved project plans within required timelines and in compliance with internal and regulatory requirements (EU, TGA, FDA)
- Quality oversight and approval of:

- Technology transfer plans, facility fits, process fits, technology transfer risk assessments, tech transfer protocols and reports, QbD process risk assessments / pFMEA, CQA assessments, process control strategy (GxP Commercial)
- System risk analysis, user requirements (URS), Qualification verification plans, test matrices, and DQ/IQ/OQ/PQ plans and reports, qualification events / discrepancies and changes
- Validation master plans, validation process and cleaning risk assessments, protocols and reports for process validation, cleaning validation, hold time validation, mixing validation, auxiliary solutions / buffer make validation, lyophilization validation, and filter validation, validation status overview matrixes, periodic monitoring for cleaning (3a and 3b transfer documents), continuous process verification (CPV) 3a and 3b plans, evaluation boards and reports, process comparability protocols and reports
- Method transfer and method validation protocols and reports
- Stability protocols and reports.
- GxP vendor qualification
- Quality Risk Assessments for relevant capital projects
- Quality oversight and contributions to changes and deviations as QA project SME
- Leading Quality Stage Gate for Design, Engineering Runs, PPQ
- Plan, coordinate, and monitor resource allocation in consideration of the project plan and CSL priorities
- Ensure that internal guidelines and global standards (quality systems, policies, procedures and work instructions) in the area of responsibility comply with regulatory requirements and industry standards
- Ensure that internal guidelines (SOPs) and global engineering standards are implemented in accordance with quality requirements

**Your Experience**
- Degree in life sciences and/or engineering
- 5+ years of experience as a professional in the pharmaceutical industry or equivalent combination of education and experience.
- Demonstrated experience in quality assurance and regulatory compliance with GxP, FDA, TGA, EU, and other regulatory agency guidelines and in manufacturing of biologics
- Direct experience in quality oversight of GMP-compliant commissioning and qualification of production facilities, equipment, and cleanrooms or validation
- Experience in interacting with regulatory authorities including submissions and inspections
- Demonstrated ability to influence at all organizational levels through clear, concise and impactful communication skills

**To apply, submit your CV no later than Monday 30th October 2024.**

**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 and inclusion. Learn more about Diversity & Inclusion at CSL.

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