Director, Plasma Supply Chain Quality – CSL Behring – Boca Raton, FL, USA
This position is a global role responsible for managing Quality-related relationships with external plasma suppliers, CSL Plasma commercial plasma activities and Supply Chain, and internal CSL Behring Quality customers.
Establish quality agreements with plasma suppliers in line with our quality system, especially the supplier management program
Collaborate with CSL Behring to ensure integrating quality requirements into plasma collection and optimizing sourcing programs to use in manufacturing global products
Represent CSL Plasma Quality in Plasma/Behring cross-business teams to develop successful tolling arrangements. Participate in and lead projects regarding plasma release processes
Role that this position reports to:
Vice President, Quality
Role/s that report to this position:
US PLC Quality Manager and EMA Qualified Person
EU PLC Quality Manager and EMA Qualified Person
Sr. Manager, Plasma Supplier Qualifications
Analyst, Supply Chain Quality
Oversee the management of Quality specifications and expectations for collected and incoming procured plasma from US and Germany donation centers. Collaborate with CSLB manufacturing site Quality and Regulatory affairs to ensure robust supply of suitable plasma and maintain plasma-related specifications to process requirements, such as transit conditions and tracking for a portfolio of plasma types.
Manage Quality performance metrics. Drive Quality progress initiatives and report significant issues and opportunities regularly to PLCs, external plasma suppliers and tolling partners. Support global commercial plasma activities by maintaining Quality-function relationships with external suppliers and CSLB Affiliates, as applicable for toll arrangements. Participate in resolving Quality issues and optimize outcomes by facilitating linkages with internal Quality resources.
Responsible for quality approved ready-to-use plasma shipments to CSL Behring fractionation sites from CSL Plasma globally. Must ensure qualified persons and inventory management systems prepare the shipments to include creating required analysis certificates to comply with regulations and optimized to meet business and manufacturing demand needs.
In collaboration Supply Chain, negotiate appropriate commercial quality terms and conditions agreements, including short supply, for the supply of purchased or toll plasma. Maintain a working knowledge of relevant regulations, quality systems and business processes in order to be successful in negotiations to identify mutually agreeable technical options.
Identify opportunities to improve quality oversight and customer service performance of our plasma supplier, especially those with potential to deliver productivity gains. Help others to envision a future state of operations, which may differ immensely from current quality operations.
Develop and manage annual and strategic plans for areas of responsibility.
Support efforts to timely gather quality information from plasma suppliers for site and CSLB Plasma master files. Reinforce expectations with relevant senior level quality management of suppliers. Collaborate to improve and automate data intensive activities that recur regularly.
Develop and execute Quality Audit System management. Ensure all audits, investigations, root cause determinations, corrective and preventive actions are appropriate for the elimination of quality-related deviations. Ensure external authority observations and suppliers throughout the organization meet quality expectations
Develop effective relationships with key Quality and Regulatory stakeholders within CSL Behring and external suppliers, as applicable. Travel internationally regularly.
Manage staff, including selecting, training, developing, coaching and terminating, as applicable with guidance from Human Resources. Appraise employee performance and provide feedback and counseling to staff, as applicable. Develop succession plans and oversee immediate staff career development.
Develop and manage to an annual budget designed to meet or exceed objectives by continuous review of performance against KPIs.
Perform other job-related duties as assigned.
Bachelor’s degree in medical technology, engineering or science required
Successful business and management experience is essential
Combined 10+ years successful senior management experience in product, quality or technical support functions in biopharmaceuticals, medical device or healthcare businesses
Working knowledge of blood banking operations, plasma center operations and/or cold chain logistics management is highly desirable
5-8 years demonstrated successful experience in highly regulated environments