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NONovartis Business Services GmbH

Site Quality Head(m/w/x)

Nürnberg, Halle (Saale), Dresden, Leipzig
Full-timeOn-siteSenior

Directing QA staff and strategic quality initiatives for GMP pharmaceutical production. 10 years in GMP pharmaceutical manufacturing experience required. Global project team collaboration.

Requirements

  • BS/MSc in Life Sciences or related experience
  • 10 years of experience in GMP Pharmaceutical Manufacturing
  • At least 3 years in Quality Control and/or Quality Assurance
  • Proven track record in supporting Quality Control operations
  • In-depth knowledge of cGMP and FDA regulations
  • Ability to manage multiple projects with moderate complexity
  • Highly developed management and communication skills
  • Strong organizational and time management skills
  • Experience in process improvement approaches

Tasks

  • Provide leadership for strategic site initiatives
  • Represent site quality in local and global project teams
  • Support and direct the Quality Assurance department staff
  • Ensure staff are qualified, competent, and motivated
  • Create user requirements and specifications for projects
  • Coordinate with stakeholders for clear communication
  • Ensure facilities and equipment are safe and compliant
  • Oversee project planning, construction, and qualification
  • Maintain updated project plans to track progress
  • Escalate risks related to timelines and budgets
  • Manage product critical quality issues and deviations
  • Ensure effective execution of investigations and CAPAs
  • Define and monitor Site Quality KPIs
  • Establish and oversee the Site Quality Committee
  • Coordinate the execution of Site Quality Plans and assessments
  • Prepare and consolidate the Quality Unit budget
  • Ensure adherence to health and safety procedures

Work Experience

  • 10 years

Education

  • Master's degree

Languages

  • EnglishBusiness Fluent

Tools & Technologies

  • Lean Six Sigma
  • Total Quality Management
  • 5S
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