Global Head of QC Raw Materials and External Testing oversight
- Employer
- CSL - Australia
- Location
- Broadmeadows, AU
- Salary
- Competitive
- Start date
- 18 Jan 2022
- Closing date
- 17 Feb 2022
View more
- Discipline
- Quality
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Experienced (non-manager)
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Job Details
The Opportunity
The Global Head of QC Raw Materials and External Testing Oversight is accountable for the development, implementation and maintenance of a standardized global Raw Materials testing and release approach, responsible for the implementation and adherence across the network and a technical global QC expert for overall External Testing. With the network of QC labs, R&D and material users in Manufacturing and Engineering s/he develops standardized specifications and leads technically the change control panel for Raw Material specification changes. Together with the local QC teams and the lead for QC in External Supplier Integration s/he assures the establishment and reliable operation of External Testing.
S/he is the global technical QC contact for issues with raw materials and suppliers, the global QC coordinator for issues with External Testing and s/he coordinates the corresponding activities within the QC network.
S/he is responsible to partner with Sourcing to optimize Sourcing strategies on optimized lot sizes, material containers, lot sharing between sites, full specification testing approach, supplier qualification testing etc.
The Global Head of QC Raw Materials is the technical key partner and SME for External Supplier Integration to evaluate, establish and maintain external testing labs.
The incumbent will be a member of the Global QC Leadership Team. This role will interact closely with R&D, Manufacturing, Engineering, Sourcing and CMOs to support Raw Material testing and release and all types of External Testing.
The role will support Operational Excellence initiatives through technical and analytical innovation.
The position requires regular travel for onsite presence in Switzerland, Germany, USA, Australia and China (10%-20%).
Your skills and experience
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!
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!
The Global Head of QC Raw Materials and External Testing Oversight is accountable for the development, implementation and maintenance of a standardized global Raw Materials testing and release approach, responsible for the implementation and adherence across the network and a technical global QC expert for overall External Testing. With the network of QC labs, R&D and material users in Manufacturing and Engineering s/he develops standardized specifications and leads technically the change control panel for Raw Material specification changes. Together with the local QC teams and the lead for QC in External Supplier Integration s/he assures the establishment and reliable operation of External Testing.
S/he is the global technical QC contact for issues with raw materials and suppliers, the global QC coordinator for issues with External Testing and s/he coordinates the corresponding activities within the QC network.
S/he is responsible to partner with Sourcing to optimize Sourcing strategies on optimized lot sizes, material containers, lot sharing between sites, full specification testing approach, supplier qualification testing etc.
The Global Head of QC Raw Materials is the technical key partner and SME for External Supplier Integration to evaluate, establish and maintain external testing labs.
The incumbent will be a member of the Global QC Leadership Team. This role will interact closely with R&D, Manufacturing, Engineering, Sourcing and CMOs to support Raw Material testing and release and all types of External Testing.
The role will support Operational Excellence initiatives through technical and analytical innovation.
The position requires regular travel for onsite presence in Switzerland, Germany, USA, Australia and China (10%-20%).
Your skills and experience
- Graduate level in Chemistry, Biochemistry, Microbiology or other related technical field. Masters/PhD degree preferred.
- Several years' experience working in Quality Assurance and Quality Control in a highly regulated industry.
- Technical knowhow on raw materials like Chemicals, Packaging Materials, Manufacturing supplies etc and the corresponding testing
- cGMP background in the Pharmaceutical industry and knowledge of relevant GMP regulations (FDA, EU, TGA).
- Knowledge of continuous improvement techniques and advanced root cause analysis techniques.
- Strong communication, negotiation and conflict management skills to influence technical experts and stakeholders at all levels in the organization.
- Ability to influence and motivate others while maintaining a cohesive team environment.
- Knowledge of pharmaceutical industry standards through active engagement in industry associations (e.g. PDA, ISPE) would be an asset.
- Lean and Six-sigma training are a plus.
- Fluent English.
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!
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!
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