Enterprise Manager, QC LIMS Automation Lead

About CSL

With operations in 35+ nations and ~ 22,000 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 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!

Job Description

This role is primarily responsible for the ongoing Development and Standardization of the business processes and structure for the use of Automation within STARLIMS platform. Working in collaboration with internal and external partners the role will lead actives which ensure there is a common approach with respect to business process and detailed requirements. The role will also serve as a Business Partner for a Site and/or Functional Group, ensuring there is appropriate and regular communication of activities along with a full understanding of stakeholders' needs, while embracing the CSL Way.

Education

• Bachelor's degree or equivalent experience; educational concentration in science, IT or engineering is preferred.

engineering is preferred.

Experience

• 7+ years of experience working within an applicable function that directly aligns with the specific responsibilities for this position.

• 5+ years of managerial, supervisory, and/or demonstrated leadership experience.

• Strong written and verbal communication skills

Competencies

• Strong project management skills. Computer literacy required. Fluent in English (written and spoken). Non-English language skills (especially German) beneficial.

• Strong presentation skills

• Strong technical writing skills in Standard Operating Procedures and Work Instruction Documents required

• High level of computer literacy with Microsoft Office products, such as Project, PowerPoint and Visio

• Knowledge of GxPs, FDA & EMEA Regulations governing validated applications including 21CFR Part 11

• Experienced skills to analyse current business process and have the capability to develop effective and innovative solutions when appropriate

Working Conditions

• Requires effective communication, collaborative and negotiation skills. Substantial experience in local and global project management, especially related to system development. Must be comfortable working in a global, matrix organization. Experience with regulatory authorities and inspections. Experience in management of teams.

• This role requires some local and overseas travel.

1. Participate in the creation and implementation of Quality Systems Strategies that are aligned with corporate business strategy and develop strategic roadmaps to support the strategic direction.

2. Responsible for ensuring the development and implementation of business processes required for the use of Automation within the STARLIMS application across all CSL Behring manufacturing sites. Responsible to identify opportunities and develop the appropriate business case/demand within the EPM process.

3. Perform Project Manager Role on an as required basis for Automation changes/development. Ensuring that project work is completed within budget and on schedule and in accordance with the CSL project management methodology as defined in EPM.

4. Excellent working knowledge of Automation based software with a specific focus on the STARLIMS platform. Propose and assess Automation design solutions based on a working knowledge of current technologies and best practices related to the functional application area. Consider industry trends and future requirements.

5. Be the point of contract, and Automation champion, for a local Site or Function. Working closely with the Site or Function to ensure transparent communication of ongoing initiatives and activities. Seek feedback from Stakeholders' to understand needs and where Quality Systems can add value to the overall process.

6. Coordinate with Sites to ensure their requirements are understood and met in the ongoing maintenance and development of Automation.

7. Act as business process lead for harmonized Automation. Ensure Automation initiatives are driving efficiencies as intended and functioning in accordance with business requirements. Lead and coordinate globally to resolve any issues for any site with Automation needs.

8. Collaborate and assist with the alignment between Quality Systems and BTQMS initiatives