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SU
SUSONITY
9h ago

Quality Operational Excellence Lead(m/w/x)

Darmstadt
Full-time, Part-timeOn-siteSenior

Description

You will sharpen the company's competitive edge by optimizing R&D processes and managing the full lifecycle of global quality procedures to ensure seamless regulatory compliance.

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Requirements

  • University degree or equivalent professional experience
  • 5 years Quality Assurance or relevant experience
  • Lean & Six Sigma or BPM certification
  • Knowledge of GCP, GVP, and GLP
  • Understanding of drug development and regulations
  • 3 years process design and writing skills
  • Proven documentation management skills
  • Analytical mindset for business strategy
  • 3 years international professional experience
  • Professional experience in project management
  • Experience in international pharmaceutical organizations
  • Fluency in English

Education

Bachelor's degree

Work Experience

5 years

Tasks

  • Deliver and review global and local procedures
  • Manage the lifecycle of GLP, GCP, and GVP procedures
  • Lead process updates with business process owners
  • Provide guidance on document structure and content
  • Advise on regulatory requirements for procedures
  • Consolidate R&D processes to drive optimization
  • Eliminate process complexities and inefficiencies
  • Advance continuous improvement initiatives for R&D
  • Maintain compliance using a risk-based approach

Tools & Technologies

Lean & Six SigmaBusiness Process ManagementGCPGVPGLP

Languages

EnglishBusiness Fluent

Benefits

Career Advancement

  • Access and growth opportunities

Informal Culture

  • Culture of inclusion and belonging

Other Benefits

  • Workplace accessibility
  • Application process accommodation
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