Regulatory Compliance Specialist

Vor 2 Tagen


Basel, Basel-Stadt, Schweiz Sobi - Swedish Orphan Biovitrum AB (publ) Vollzeit
Key Responsibilities
  • Compliance Management: Ensure adherence to GMP & GDP regulations, quality technical agreements, and Sobi's procedures and policies.
  • Supplier Qualifications: Oversee supplier qualification, validation, and performance monitoring.
  • Quality Risk Assessments: Implement and maintain quality risk assessments and KPIs to identify and mitigate potential quality risks.
  • Communication: Serve as the primary contact for all quality-related activities with external suppliers, internal stakeholders, and regulatory authorities.

Required Skills and Qualifications

  • Bachelor's degree in pharmacy, medicine, veterinary medicine, chemistry, technology, or natural science.
  • More than 10 years of experience in pharmaceutical or biotech industry, preferably with a background in quality assurance or regulatory affairs.
  • Strong understanding of GMP & GDP regulations, quality management systems, and regulatory requirements.
  • Excellent communication, interpersonal, and leadership skills.


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