QMS Process Optimisation Lead
The Opportunity:
We are looking for a dynamic and experienced QMS Process Optimization Lead to join our Quality Management Systems (QMS) team. You will help enhance our Quality Management Systems, ensuring they are efficient, effective, and aligned with our global standards. As a regional Lead, you will utilize Lean and agile methodologies to optimize Quality Management Systems (QMS) processes and related procedures across our manufacturing, Plasma, or R&D sites to enhance business performance. You will partner with the Analytics and Reporting team evaluating data to identify opportunities for improvement across the Quality Management system.
This is MAT replacement role and Fixed term (secondment for internal candidates) opportunity until 30th September 2025.
The Role:
Reporting to the Head of QMS Framework Governance, your key responsibilities include:
- Continuous Improvement: Identify and lead initiatives to enhance QMS performance by examining key performance indicators and partnering with site resources to prioritize and simplify processes.
- Project Leadership: Develop and execute project plans, engage local resources, and lead efforts to reduce complexity in local QMS.
- Change Agent for QMS projects: Support QMS BPO with implementation of QMS major projects through participation in system design, procedural alignment, and validation activities. Partner with BPOs to create and deliver enterprise training material and learning experiences at the site to educate stakeholders on the overall QMS program. Lead local implementation through communication with site leadership, monitoring progress and escalation of issues.
- Collaboration: Work closely with Business Process Owners (BPOs) and the training and documentation team to ensure local policies and procedures are aligned with the QMS framework and fit for purpose.
- Subject Matter Expertise: Maintain and share knowledge on the QMS framework, acting as the primary point of contact for the region or function.
Experience:
- Master's degree in pharmaceutical science, business administration, or a related field.
- Minimum of 5 years of experience in a process optimization role.
- Understanding of GMP QMS requirements for Deviation/CAPA, Change Management and Complaints is desired.
- Proven track record of driving transformational change programs.
- Experience with data analytics.
- Understanding of the regulatory environment (GMP) specific to life sciences is preferred.
Why Join Us?
At CSL, we are committed to fostering a culture of continuous improvement and innovation. Join us and be part of a team that is dedicated to making a difference in the lives of patients worldwide.
How to Apply?
Please submit your applications with your resume and cover letter detailing their qualifications and experience. Applications close by 2nd December 2024.
#LI-Hybrid
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 Opportunity:
We are looking for a dynamic and experienced QMS Process Optimization Lead to join our Quality Management Systems (QMS) team. You will help enhance our Quality Management Systems, ensuring they are efficient, effective, and aligned with our global standards. As a regional Lead, you will utilize Lean and agile methodologies to optimize Quality Management Systems (QMS) processes and related procedures across our manufacturing, Plasma, or R&D sites to enhance business performance. You will partner with the Analytics and Reporting team evaluating data to identify opportunities for improvement across the Quality Management system.
This is MAT replacement role and Fixed term (secondment for internal candidates) opportunity until 30th September 2025.
The Role:
Reporting to the Head of QMS Framework Governance, your key responsibilities include:
- Continuous Improvement: Identify and lead initiatives to enhance QMS performance by examining key performance indicators and partnering with site resources to prioritize and simplify processes.
- Project Leadership: Develop and execute project plans, engage local resources, and lead efforts to reduce complexity in local QMS.
- Change Agent for QMS projects: Support QMS BPO with implementation of QMS major projects through participation in system design, procedural alignment, and validation activities. Partner with BPOs to create and deliver enterprise training material and learning experiences at the site to educate stakeholders on the overall QMS program. Lead local implementation through communication with site leadership, monitoring progress and escalation of issues.
- Collaboration: Work closely with Business Process Owners (BPOs) and the training and documentation team to ensure local policies and procedures are aligned with the QMS framework and fit for purpose.
- Subject Matter Expertise: Maintain and share knowledge on the QMS framework, acting as the primary point of contact for the region or function.
Experience:
- Master's degree in pharmaceutical science, business administration, or a related field.
- Minimum of 5 years of experience in a process optimization role.
- Understanding of GMP QMS requirements for Deviation/CAPA, Change Management and Complaints is desired.
- Proven track record of driving transformational change programs.
- Experience with data analytics.
- Understanding of the regulatory environment (GMP) specific to life sciences is preferred.
Why Join Us?
At CSL, we are committed to fostering a culture of continuous improvement and innovation. Join us and be part of a team that is dedicated to making a difference in the lives of patients worldwide.
How to Apply?
Please submit your applications with your resume and cover letter detailing their qualifications and experience. Applications close by 2nd December 2024.
#LI-Hybrid
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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