Head Of Lab Execution Systems

6 days ago

Melbourne, Victoria, Australia Csl Full time

The Opportunity

The Role
- Lead/provide the strategy for implementation, improvement, qualification, lifecycle and sustainability of Laboratory Execution Systems.
- Govern the process and ensure adherence to global procedures, standards, design/validation documentation, and training documents relating to the implementation and lifecycle of the lab systems, instruments, and interfaces in scope.
- Work with the Quality Control, Global Execution Systems, Computer Systems Validation, and Information & Technology teams to identify and pursue improvements of LES processes (system security, data integrity, configuration, master data definition, and data contextualization).
- Responsible for compliance requirements, audit readiness/response, and system administration; develop reporting dashboards, standard views and dashboards; provide technical support and troubleshooting for issues and incidents.
- Provide oversight to MSP for lab equipment/instrument and system support, uptime, maintenance, change control, and life-cycle activities.

Your Skills & Experience
- Bachelor of Science (BS) degree in engineering, Computer Science, or a relevant scientific discipline (Chemistry, Biology, Microbiology, etc.); advanced degree preferred.
- 5+ years' work experience, with at least 10+ years' experience in pharmaceutical manufacturing quality management in a cGMP environment.
- 5+ years' experience in pharmaceutical Quality Control laboratory processes.
- 5+ year of management experience.
- Experience influencing the industry on laboratory execution systems through publications and presentations is strongly preferred.
- Experience managing, building, and deploying, transformational laboratory execution systems across a global organization.
- Demonstrated ability to influence at all organizational levels through clear, concise, and impactful verbal and written communication skills.
- Build, mentor, and grow a cohesive team.
- Knowledge of quality by design concepts and Regulatory (e.g. FDA and EMA) requirements.
- Work across a range of countries and cultures.

**Our Benefits**:
CSL employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL offers resources and benefits, from health care to financial protection, so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family, need help paying for emergency back up care or summer camp, looking for mental health resources, planning for your financial future, or supporting your favorite charity with a matching contribution, CSL has many benefits to help achieve your goals.

Please take the time to review our benefits site to see what's available to you as a CSL employee.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organization with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

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