Manager, Global Quality Engineering C&q

The Manager, Global Quality Engineering Commissioning & Qualification is responsible for quality oversight of GMP compliant commissioning and qualification of utilities and production facilities, equipment, and cleanrooms for CAPEX and OPEX projects (local and global). This includes review and approval of all user requirements, risk assessments, protocols and reports related to commissioning and qualification activities.

The incumbent will be the Quality partner to the teams within of Global Engineering and work closely with members of Global Engineering. The incumbent will work closely with his or her peers in Quality Engineering, Site QA as well as QA-Sterility Assurance across the different manufacturing sites and ensure that the same principles and systems are applied across all CSL Behring manufacturing sites and that in all projects, the appearance of the documentation in the stated areas is standardized.

**Your role**:
Reporting to the Associate Director Global Quality Engineering Lead you will ensure GMP-compliant planning and implementation of projects in the area of Commissioning & Qualification:

- Perform QA activities, including issue and risk management for local and global CAPEX and OPEX projects in the area of Commissioning & Qualification
- Provide a consistent quality approach to utilities, production facilities, equipment, and cleanrooms, with attention to process design
- Ensure GMP compliant execution of commissioning and qualification 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 risk analysis, user requirements (URS), factory acceptance testing (FAT), on-site acceptance testing (SAT), and DQ/IQ/OQ/PQ plans and reports as part of local and global CAPEX and OPEX projects
- 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 in the area of Commissioning & Qualification.

**Experience**:

- Degree in life sciences and/or engineering; Advanced degree preferred.
- 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
- 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

This role is offered as a 12 month fixed term contract and a secondment may also be considered.

**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**: