Director, Quality System Standards

Company: CSL Behring
Location: Boca Raton
Posted on: May 23, 2020

Job Description:

With operations in 35+ nations and - 20,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.CSL is the parent company of CSL Behring and Seqirus.CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operatesCSL Plasma , one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is the second largest influenza vaccine company in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!ResponsibilitiesQualificationsCSL Behring, a global biopharmaceutical company, is looking for a Director, Execution & Quality System Standards & Governance who will be responsible for developing & supporting the implementation of execution systems and quality systems standards including supporting governance model*This position can be based at any CSL location. Responsibilities:Responsible for development of standards that support recipe-driven manufacturing execution systems across the manufacturing network for all batch processing activities from lab to patient. Supports implementation of standards across the manufacturing network as the champion for the utilization of standards. Scope of execution system standards includes recipe libraries, recipe management, process control and data historian activities related to batch production, testing and release. Develop and maintain a road map of current and future execution systems, aligned with the developed standards.Responsible for development of standards that support the enterprise Quality execution systems including LIMS and other quality management system digital solutions. Develop, implement and own the governance of execution system standards. Continuously monitor adherence to the standards and identify opportunities for improvement. Qualifications:10+ years' work experience, with at least 5 years' experience in GMP execution systemsSpecific experience in process automation, MES and batch manufacturing industry standards (ISA S88 &S95) Direct experience designing, building, deploying and supporting automation and execution systems (SCADA, MES, PAT, OSI Pi Data historian, etc.) in a regulated large-scale process-based manufacturing environmentDemonstrated ability to influence through clear, concise and impactful verbal and written communication skillsExperience in Process Excellence methodology is desirable, but not required.Ability to work across a range of countries and culturesAbility to travel up to 20% domestically and internationally (*when not restricted)Bachelor of Science in an Engineering or other Science discipline, Computer Science, or Management Information Systems.Competencies:Customer Orientation (Internal/External): Creates companywide strategies to stay ahead of industry-related changes. Drives alignment across the enterprise in order to serve customer needs. Spends time internally and externally with customers and stakeholders and genuinely seeks to understand their needs.Enterprise Results and Value Orientation: Looks for outcomes that maximize the benefits for the enterprise, not just their department or function. Pursues value realization for the enterprise even if their function does not benefit.Collaboration and Influencing:Champions a culture of inclusiveness and teamwork. Collaborates effectively with others and influences all stakeholders towards enterprise outcomes. Embraces conversations needed to deliver enterprise value.Strategic/Innovative: Global perspective. Takes a broad view when approaching issues. Sees ahead to future possibilities & translates to breakthrough strategies. Collaborates to influence strategies of others, and adapts own strategy towards enterprise value.Change Management:Mobilizes others to initiate change; builds group momentum for change; embeds culture of change. Aligns change to enterprise strategies and direction.Interpersonal Savvy: Relates well to all kinds of people, up, down and sideways, inside and outside the organization; builds appropriate rapport; builds constructive and effective relationships; uses diplomacy and tact; can diffuse even high-tension situations comfortably.CapabilitiesWorker Type:EmployeeWorker Sub Type:Regular

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