Execution Systems Standards & Governance Lead

About CSL

With operations in 35+ nations and ~27,000 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 operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL's therapies. Seqirus is one of the largest influenza vaccine companies 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!

Job Description

The Execution Systems Standards & Governance Lead is responsible for the implementation and documentation of Execution Systems standards used globally, including the supporting to the governance model. Implements standards across the manufacturing network as a champion for the utilization of standards and utilizes a governance model to ensure standards are maintained.

Principal Accountabilities: Itemize the separate duties and responsibilities of the position. Fully detail each major task or responsibility necessary to correctly perform the position function. The tasks are ranked from those most crucial in the beginning of the section to those, which are more routine in the end of the section.

1 Develop, document, and implement standards:

• Support the governance of Execution System standards. Continuously monitor adherence to the standards and identify opportunities for improvement.
• Create and maintain department dashboard, monitoring and report on goals, objectives, and KPI's.
• Coordinate and communicate the Standards Roadmap.
• Develop and institutionalize standards for workflow management, including deployment of the Incident Management, Change Management, and Problem Management processes.
• Develop standards for vendor management and Master Service Agreements
• Manage governance as part of the Center for Excellence.

2 Collaboration across CSL network:

• Translate stakeholder needs into attributes, collaborate to align on best practices which form the basis for Design Standards.
• Partner with Peers from Quality, Safety, and IT/Automation to align on requirements, content, and boundaries for the engineering Knowledge and Documentation.
• Facilitate all Standards & Governance activities, meetings, and changes.
• Ensure that affiliate personnel, Corporate Compliance and the Affiliate Compliance Officer are supported as needed concerning internal audits and compliance activities (e.g.: Corporate Compliance quarterly monitoring).

Education:

Minimum a Bachelor's in Engineering, Computer Sciences or similar.

Related Experience:

• 7+ years of practical leadership experience in the pharmaceutical industry, including expertise in manufacturing, engineering, or information systems.
• Demonstrated experience with Engineering and Automation Design Standards knowledge management and maintaining across the life cycle.
• Experience with workflow management related to automation deliverables and standards and the related administration.
• Experience with industry standards (ISA S88, S95, GAMP5) and best practices, cGMPs, and Regulations.
• Experience with Project Management and Project Portfolio (PMO, PMI)