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. This includes hosting relevant change panels, providing training to Global Logistics Quality teams and stakeholders, and Affiliates to ensure compliant completion of GCC activities. You will also support inspection readiness for change control topics and monitor the GCC system through related KPIs. Additionally, you will serve as an SME for Global Quality Logistics within the global community of practice and contribute to GCC improvement initiatives.
You will support affiliates in maintaining compliant change control processes. Your role involves quality assurance for logistics processes, including:
* Transport verification and compliance
* Deviations, CAPA, and continuous improvement initiatives within CSL's global distribution network, acting as a quality approver for GxP activities
* Providing quality compliance support and oversight over Enterprise Logistics distribution centers, contractors, and 3PLs/4PLs
* Monitoring the quality system through KPIs, monthly reports, and Quality Management Reviews
* Escalating non-compliances according to global guidelines
The team acts as a single point of contact for logistics quality-related topics across CSL departments and business units. You may deputize for team members or the supervisor as needed. Limited national/international travel (<10%) may be required to support functions or attend global meetings.
Position Qualifications and Experience Requirements
* University degree in a scientific discipline, life sciences, logistics, or project/business management. Candidates without a degree but with at least 5 years of relevant experience in Quality Management Systems, Change Control, or Quality Assurance will also be considered.
* Minimum 5 years of experience in change control within the pharmaceutical industry GxP roles
* Excellent communication and collaboration skills
* Computer literacy required
* Fluency in English is required; proficiency in German, Spanish, or Portuguese is beneficial
* Limited travel required
Our Benefits
We prioritize your well-being. Learn more about how we care at CSL.
About CSL Behring
CSL Behring is a global biotherapeutics leader committed to saving lives. We focus on serving patients with innovative therapies in immunology, hematology, cardiovascular, metabolic, respiratory, and transplant areas, using plasma fractionation, recombinant proteins, and gene therapy. Our parent company, CSL, based in Melbourne, Australia, employs 32,000 people and delivers therapies in over 100 countries.
Our Commitment to Inclusion
At CSL, Inclusion and Belonging are core to our mission. We celebrate diversity and foster a culture of curiosity and empathy to better serve our patients and stakeholders. Learn more about our Inclusion and Belonging initiatives.
Join us to do work that matters at CSL Behring!
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