CSL Plasma Inc. | Head of Lab Execution Systems, Senior Director
hace 2 semanas
Apply locations Americas, US-PA, King of Prussia, CSL Behring Americas, US-IL, Kankakee, CSL Behring APAC, AU, Broadmeadows, Seqirus EMEA, CH, Kanton Bern, Bern, CSL Behring APAC, AU, Victoria, Parkville, CSL Limited Melbourne time type Full time posted on Posted 16 Days Ago job requisition id R-245124
The Opportunity
The Senior Director, Head of Lab Execution Systems (LES) will lead our Systems support across our Quality Control labs that help produce commercial and clinical trial materials. This includes enterprise systems such as STARLIMS, LabWare, Empower, Nugenesis, and Chromeleon, along with local QC lab instrument applications. Your work also includes managing laboratory interfaces across equipment and instruments, electronic lab workflow applications, Laboratory Information Management Systems (LIMS), Manufacturing Execution Systems (MES), Enterprise Resource Management (ERP) systems, and data repositories. Furthermore, you will lead the development and implementation of a global LES strategy based on established standards, allowing the manufacturing QC labs to operate reliably while using electronic workflows and contextualized data to support the success of test methods, process outcomes, and batch release.
The Role
- Lead/provide the strategy for implementation, improvement, qualification, lifecycle and sustainability of Laboratory Execution Systems.
- Lead and provide strategic direction to a global team accountable for delivering (Opex & Capex), and lifecycle of Laboratory Information Management Systems (LIMS), QC Lab Enterprise Systems, Electronic Lab Method Execution applications, and QC Lab instrument applications.
- 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.
- 10+ years' direct experience in building, deploying, and supporting QC lab operational technology systems (eg. LIMS, Digital Method applications, Instrument systems, Interfacing, etc.)
- 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.
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.
About CSL BehringCSL 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.
We want CSL to reflect the world around usAs a global organization with employees in 35+ countries, CSL embraces diversity and inclusion.
Do work that matters at CSL Behring Equal Opportunity EmployerCSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please click here.
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