Senior QA Professional Investigational Medicinal Product

Vor 7 Tagen


Basel, Basel-Stadt, Schweiz Sobi - Swedish Orphan Biovitrum AB (publ) Vollzeit

We are looking for a Regulatory Compliance Specialist for our Investigational Medicinal Products (IMPs). As a key member of our team, you will be responsible for ensuring the quality and compliance of our products, maintaining oversight of quality topics for Sobi IMPs across markets, and continuously improving work processes related to quality and compliance of IMPs.

The ideal candidate will have a strong understanding of GMP & GDP regulations and a minimum of 10 years of experience within pharmaceutical or biotech product development. You will act as the primary quality liaison for external suppliers, organizing inquiries, investigations, and audit follow-ups, and ensure compliance with Quality Agreements.

To succeed in this position, you will need to possess excellent critical reasoning, risk-analysis, and problem-solving skills, as well as interpersonal and leadership skills. A Bachelor's degree in life sciences is required, and fluently spoken and written English is essential.



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