Critical Investigator (Pharmaceutical, Kvistgård or Munich)

Job summary

This role involves leading critical investigations in a global vaccine company, focusing on quality, processes, testing, and operational challenges. The position is temporary and will operate from either Kvistgård, Denmark, or Munich, Germany.

Qualifications

• PhD, MD, or equivalent research experience in Pharmaceutical Science, Cell Culture, Chemical Engineering, Process Engineering, or a related field.
• Proven experience in independent analytical thinking and root-cause analysis.
• Strong understanding of manufacturing principles and complex engineering processes.
• Ability to collaborate with data support teams for statistical studies and data analysis.
• Fluency in communicating complex scientific topics to various stakeholders.

Responsibilities

• Lead and coordinate investigations related to Deviations, Out of Specification (OOS), Out of Trend (OOT), and Out of Expectation (OOE) issues.
• Facilitate systematic root-cause analysis with subject matter experts.
• Communicate investigation status and findings to stakeholders and upper management.
• Support the development of Corrective and Preventive Actions (CAPA), recommendations, and investigation memos.
• Provide scientific advice to associated departments and coordinate with external research labs and testing sites.

Skills

• Strong analytical and structured approach to problem-solving.
• Ability to engage specialists and align stakeholders effectively.
• Excellent communication skills to simplify complex scientific information.

Education

• Advanced degree (PhD, MD, or similar) in a relevant scientific field.

Tools

• Familiarity with statistical analysis tools and data management software.