Deviation Manager (m/w/d)

Contract start date: 02/03/2026

Contract end date: 31/08/2026

Responsibilities:

• Responsible to own, author, record and investigate Deviations.
• Liaise with Subject Matter Experts and key stakeholders to establish the root cause of deviations and the potential impact of said deviations.
• Ensure proper investigational tools are used to systematically define the root cause(s) and contributing factor(s) (e.g., Fault Tree Analysis, Defense Analysis, Event & Causal Factors Chart, Fishbone Diagram, etc.).
• Contribute to define appropriate CAPA, and associated Effectiveness Checks, as solutions to correct deviations and prevent future recurrence.
• Ensure cGMP compliance through the investigation process, and to drive their quality records to completion and timely closure.
• Support the business through ongoing change and process improvement activities.

Requirements:

• Bachelor degree in chemistry, biotechnology, life science or related field.
• Previous experience in Deviations and cGMP in a regulated pharmaceutical/API industry.
• Knowledge of biotech. manufacturing processes and analytical methods is an advantage.
• Experience with Human and Organizational Performance & risk management approaches is an advantage
• Fluency in English, both written and spoken. German is an advantage.
• Technical writing & presentation/communication skills are key for the role.