Head of Quality Assurance | Life Scientist (m/w/d)
CatalYm GmbH
Job Summary
This senior leadership role requires a Head of Quality Assurance to lead the entire QA department, overseeing all GxP activities, with a primary focus on GMP and GCP within clinical development and safety. The successful candidate will be responsible for establishing and maintaining a robust Quality Management System (QMS), potentially driving the transition to an electronic solution, and implementing risk-based quality oversight strategies. A core function involves ensuring company-wide inspection readiness across all departments, managing regulatory GxP inspections, and aligning quality initiatives with C-level executives. This position requires an advanced degree and significant experience—10+ years in the pharmaceutical or biotech industry, including at least 5 years specifically in QA or Compliance, coupled with a strong clinical development background. The role offers the opportunity to contribute directly to cutting-edge oncology programs in an agile, collaborative biotech environment, providing flexibility and professional growth.
Required Skills
Education
Advanced degree in Life Sciences, Pharmacy, or Medicine
Experience
- 10+ years in pharmaceutical or biotech industry
- At least 5 years in Quality Assurance or Compliance
- Professional experience in clinical development
- Experience in preparing for and managing regulatory inspections
Languages
Additional
- Flexibility for travel on an as needed basis
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