Head of QC Laboratory Bioanalytics | Biologe (m/w/d)
Daiichi Sankyo Europe GmbH
Job Summary
As the Head of QC Laboratory for Bioanalytics at Daiichi Sankyo's Pfaffenhofen site, you will lead a specialized team within pharmaceutical quality control focusing on Antibody-Drug Conjugates (ADCs). Your daily responsibilities include the technical and disciplinary management of the bioanalytics group, ensuring all testing aligns with GMP regulations, marketing authorizations, and current scientific standards. You will be responsible for the robust execution of QC processes, evaluating deviations (OOS/OOT), and approving critical quality documentation. This role is highly collaborative, requiring close coordination with Quality Assurance, Production, and Qualified Persons (QPs). You will also represent the department during internal and external audits and inspections. This position is ideal for a leader who thrives in a high-stakes environment, offering the chance to shape cutting-edge oncology therapies while benefiting from an attractive corporate culture that emphasizes work-life balance and personal growth.
Required Skills
Education
University degree in Natural Sciences, preferably in Biochemistry, Molecular Biology, or Pharmacy.
Experience
- Several years of professional experience in bioanalytics with deep technical knowledge of ADC analysis
- Extensive experience in pharmaceutical quality control and GMP environments
- Proven leadership experience with the ability to manage and inspire teams in complex regulatory settings
- Experience in handling deviations, CAPAs, and change control processes
- Experience representing departments during inspections and audits
Languages
Additional
- Must fulfill the requirements for Head of Quality Control according to §12 AMWHV and EU-GMP guidelines. Position is based in Pfaffenhofen, Germany.
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