As a Manager for Global Quality Affiliates and Logistics Operations, you will be responsible for maintaining a compliant Global Change Control system for the global logistics organizations in alignment with Global QMS, including hosting relevant change panels, provide training to Global Logistics Quality (and stakeholders) as well as Affiliates for compliant completion of GCC activities, inspection support/inspection readiness assurance for change control topics. You will also be expected to monitor the GCC system through GCC related Key Performance Indicators (KPIs) and act as an SME for Global Quality Logistics in global community of practice and GCC improvement initiatives.
You will equally support the affiliates for compliant change control as described above.
In this role, you will be a part of the team responsible for quality assurance for logistics processes, including:
* Transport verification and compliance
* Deviations, CAPA and continuous improvement initiatives for CSL global distribution network in Enterprise Logistics, including quality approver for GxP activities
* Quality compliance support and quality assurance oversight over Enterprise Logistics distribution centres, contractors and 3PLs/4PLs
* Monitoring the quality system in Enterprise Logistics through related Key Performance Indicators (KPIs), monthly reports and Quality Management Reviews
* Escalation of non-compliances according to global guidelines,
The team supports other CSL departments and business units as a single point of contact for all logistics quality-related topics.
You will be deputizing for other team members and, if required and qualified, for supervisor of the team.
In this position you might also be expected to do some limited national/international travel (<10% of time) to support relevant functions or attend global meetings within CSL Behring
Position Qualifications and Experience Requirements:
* Education: University degree, preferentially in Scientific Discipline/Life Sciences, logistics operations or Project/Business Management (candidates without university degree and candidates with degrees in other fields as listed above will be considered depending on the level of relevant experience (minimum 5 years) in Quality Management Systems, Change Control or Quality Assurance)
* 5+ years of experience working in change control within relevant pharmaceutical industry GxP roles
* Excellent personal, communication and collaboration skills
* Computer literacy required
* Fluency in English language required, fluency in German or any other languages (especially Spanish or Portuguese) is beneficial.
* This role requires limited travel.
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 biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.
We want CSL to reflect the world around us
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging | CSL.
Do work that matters at CSL Behring!