Senior Analytics & Reporting Specialist - Quality Systems (m/w/x) at CSL

Marburg, Hessen, Germany

CSL Logo
Not SpecifiedCompensation
Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Biotechnology, PharmaceuticalsIndustries

Requirements

  • Degree (BSc) or equivalent in data science, IT or comparable
  • Knowledge in data modelling (Inmon, Kimball, Star Schema, Snowflake Schema)
  • Project management skills and knowledge in biotech related business processes (GxP)
  • Fluently in English verbal and written
  • More than 5 years’ experience in the above-mentioned field
  • Profound knowledge of data structures in TrackWise and Veeva Quality Management System
  • Knowledge of data structures in SAP QM, Labware LIMS, and StarLIMS preferred
  • Experienced with data analytics tools such as SAP BW, SAP Native HANA, Qlik Sense, Microsoft Fabric, and Microsoft Power BI
  • Knowledge about KPIs in the Quality environment, distinguishing between Leading and Lagging KPIs
  • Experience in creating new insights based on data and visualizing them in meaningful charts
  • Experience in setting up data structures for AI usage, fine-tuning large language models (LLMs), and implementing retrieval-augmented generation (RAG) techniques is preferred
  • Understanding of Quality business processes and the ability to translate business requirements into technical solutions
  • Ability to document business requirements in User Requirement Specifications and Functional Specifications
  • Ability to document technical implementations in Design Specifications

Responsibilities

  • Develop and maintain advanced data analytics solutions to support Quality business processes
  • Automate the calculation and visualization of Quality KPIs to provide actionable insights
  • Understand and support relevant QMS business processes, including Deviation, CAPA, and Complaint management. Ensure data analytics solutions are aligned with these processes
  • Work closely with Business Process Owners (BPOs) and other stakeholders to ensure data analytics solutions meet business needs
  • Partner with IT and other departments to integrate data from various sources
  • Manage and support global, complex data analytics projects. Develop project plans, engage local resources, and ensure timely delivery of project milestones
  • Identify opportunities for improvement in data analytics processes and tools
  • Stay updated with the latest trends and technologies in data analytics and AI

Skills

Data Analytics
Reporting
KPI Automation
Data Visualization
Quality Management Systems
CAPA Management
Deviation Management
Complaint Management
Project Management
AI

CSL

Develops biotherapies and influenza vaccines

About CSL

CSL develops and delivers biotherapies and influenza vaccines, focusing on rare and serious diseases. Their products include plasma-derived and recombinant therapies, which are created through extensive research and development. CSL serves a wide range of clients, including healthcare providers and governments, across the Americas, Asia Pacific, and Europe. What sets CSL apart from competitors is its comprehensive portfolio and commitment to addressing rare diseases, alongside a strong emphasis on diversity and inclusion within its workforce. The company's goal is to save lives and protect health through its innovative therapies and vaccines.

Parkville, AustraliaHeadquarters
1916Year Founded
$2,628.7MTotal Funding
ACQUISITIONCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees

Risks

Emerging synthetic biomaterials may reduce demand for traditional plasma therapies.
Jumar Bioincubator could increase local competition in the biotech sector.
CSL may need to adapt to the rising effectiveness of cell-based influenza vaccines.

Differentiation

CSL offers the broadest range of plasma-derived and recombinant therapies globally.
CSL's self-amplifying mRNA COVID-19 vaccine provides longer immunity at lower doses.
CSL's MF59® adjuvant enhances immune response, crucial for pandemic preparedness.

Upsides

CSL's garadacimab could be the first monthly treatment for hereditary angioedema.
CSL's cell-based influenza vaccine shows higher effectiveness over egg-based vaccines.
CSL's gene therapy HEMGENIX® offers a one-time treatment for haemophilia B.

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