Head of Quality Control
Vor 2 Tagen
Head of Quality Control & Analytical Development
A pioneering biopharmaceutical company developing next-generation therapeutics — is seeking a Head of QC & Analytical Development to take strategic and operational ownership of all analytical and quality control activities across their German manufacturing site.
The Role
- Lead and develop multidisciplinary QC and Analytical teams (Analytical Development, Raw Material, In-Process, Release, and Stability testing)
- Oversee method development, qualification, validation, and transfer of analytical methods supporting both Drug Substance and Drug Product manufacturing
- Ensure full GMP compliance for all QC operations, including data integrity, investigations, and regulatory inspections
- Act as the key technical authority for analytical strategy, working closely with QA, Manufacturing, Regulatory Affairs, and R&D
- Drive continuous improvement initiatives and analytical lifecycle management to enhance efficiency and scientific robustness
- Represent QC in cross-functional CMC and tech transfer projects, both internally and with external partners or CMOs
Your Background
- Degree (PhD, MSc, or equivalent) in Chemistry, Biochemistry, Pharmaceutical Sciences, or related field
- 10+ years' experience in QC and/or Analytical Development within biologics, radiopharmaceuticals, or advanced therapies
- Proven leadership experience managing QC laboratories in a GMP-regulated environment
- Strong knowledge of analytical techniques (HPLC, GC, CE, spectroscopy, bioassays) and regulatory guidelines (ICH, EMA, FDA)
- Experience in tech transfer, method validation, and regulatory submissions highly desirable
- Fluent in English & German language skills advantageous
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