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Miltenyi Biotec
5d ago

QA Manager for Commercial Manufacturing ATMP(m/w/x)

Bergisch Gladbach
Full-timeWith Home OfficeExperienced

Description

You will safeguard quality standards for life-changing therapies by overseeing GxP compliance and inspection readiness while driving continuous improvements across the cell factories.

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Requirements

  • •Degree in Pharmacy, Biology, Biochemistry, Medicine, or comparable qualification
  • •Several years of commercial pharmaceutical experience
  • •Solid experience across various QA functions
  • •Strong knowledge of international cGxP regulations
  • •Familiarity with aseptic processes and CGT
  • •Knowledge of development requirements and GCP (plus)
  • •Experience hosting health authority inspections
  • •Excellence in critical communication and risk-mitigation
  • •Fluent English and German skills
  • •Excellent presentation skills and analytical mindset

Education

Bachelor's degree

Work Experience

approx. 1 - 4 years

Tasks

  • •Oversee commercial cell and gene therapy products
  • •Ensure inspection readiness through cross-departmental collaboration
  • •Monitor commercial manufacturing for GxP compliance
  • •Enforce quality standards and regulatory requirements
  • •Assess and implement new regulatory requirements
  • •Approve batch records, SOPs, and risk assessments
  • •Drive continuous improvement of quality systems
  • •Align QA topics across multiple cell factories
  • •Foster transparent communication with external partners
  • •Eliminate audit deficiencies and track corrective actions
  • •Support decentralized and point-of-care manufacturing approaches
  • •Lead QA-related decision-making for external activities
  • •Monitor and support employee qualification programs

Tools & Technologies

cGxPCell & Gene Therapy (CGT)GCPGMP

Languages

English – Business Fluent

German – Business Fluent

Benefits

Informal Culture

  • •International teams
  • •Intercultural communication
  • •Room for creativity
  • •Inclusive and collaborative environment

Healthcare & Fitness

  • •Corporate sports activities
  • •Health provision

Learning & Development

  • •Inhouse Training Academy

Team Events

  • •Employee events

More Vacation Days

  • •30 days of vacation

Company Bike

  • •(e)-bike leasing

Retirement Plans

  • •Company pension plan
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