Freelance Quality Manager / Senior Expert Fill & Finish – FDA Inspection Readiness (m/f/d)

Pfaffenhofen an der Ilm 01.09.2026

What is Freelance Quality Manager / Senior Expert Fill & Finish – FDA Inspection Readiness (m/f/d)?

Freelance Quality Manager / Senior Expert Fill & Finish – FDA Inspection Readiness (m/f/d) is an exciting career opportunity based in Pfaffenhofen an der Ilm. This role offers competitive compensation and the opportunity to work in the technology sector with modern tools and methodologies.

Employment Type: Remote possible: true

Work Arrangement: Remote work available with flexible scheduling

Industry: Information Technology & Professional Services

Complete Job Description

For the strategic and operational preparation of an upcoming FDA inspection of a newly established, state-of-the-art production area for the aseptic filling and freeze-drying of sterile pharmaceuticals, we are seeking a Freelance Quality Manager / Senior Expert Fill & Finish – FDA Inspection Readiness (m/f/d). The project is limited to 6 months until February 28, 2027 (extension possible) and is full-time (1 day/week remote). We look forward to receiving your application! FDA Readiness: Advising...

What skills are required for this freelance quality manager / senior expert fill & finish – fda inspection readiness (m/f/d)?

The essential skills and qualifications for this position include:

Education: Degree in Pharmacy, Biotechnology, Process Engineering, Chemistry, or a comparable field. Professional Experience: At least 10 years of operational experience in sterile pharmaceutical manufacturing (GMP environment). Specialization: In-depth operational experience in aseptic filling and freeze-drying (Fill & Finish). Track Record: Demonstrable success in preparing for and participating in FDA inspections in sterile environments. Regulatory Knowledge: Sound knowledge of FDA (21 CFR Parts 210/211), EU GMP, and specifically Annex 1. Technology: Knowledge of sterile filtration, isolator technology, cleanroom classifications, environmental monitoring (EM), media fills (APS), and contamination control strategy (CCS). Processes: Confident handling of deviations, CAPA, change control, qualification, and validation. Languages: Fluent in German and English.

Additional preferred qualifications may include problem-solving abilities, strong communication skills, and experience working in collaborative team environments.

What type of employment is this freelance quality manager / senior expert fill & finish – fda inspection readiness (m/f/d)?

This is a Remote possible: true position offering:

  • Competitive compensation in EUR currency
  • Remote work flexibility
  • Professional development opportunities
  • Modern technology stack and tools

How can I apply for this freelance quality manager / senior expert fill & finish – fda inspection readiness (m/f/d)?

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