Regulatory Compliance Manager

2 days ago


Stockholm, Stockholm, Sweden Sobi - Swedish Orphan Biovitrum AB (publ) Full time

About the Role

We are seeking a highly skilled Regulatory Compliance Manager to join our team at Sobi. As a key member of our Quality Assurance department, you will be responsible for leading and managing Computer System Validation (CSV) and ensuring e-compliance of GxP systems.

Key Responsibilities:

  • Ensure eCompliance: Oversee GxP system lifecycle management, manage Quality Data Stewards, evaluate and approve high-level quality concepts and documents, and support CSV inspections and internal audits with follow-up activities and remediation guidance.
  • Csv Standards and Implementation: Define, maintain, and serve as the single point of contact (SPOC) for corporate Computerized Systems Compliance (Csv) standards across the company. Enable divisions and business units to implement these global Csv standards. Lead the development and enforcement of these standards.
  • Compliance Verification: Implement Sobi Csv standards and verify compliance through periodic reviews, ensuring adherence to current GxP and company requirements. Lead the compliance verification process to maintain high standards.

Requirements

To be successful in this role, you will need:

  • A bachelor's degree in Life Sciences, Engineering, Computer Science, or related field.
  • Minimum 10 years of experience in the pharmaceutical industry within Quality systems, manufacturing, R&D, or regulatory affairs, with at least 4 years in a leadership role.
  • Strong understanding of GxP regulations, including FDA, EMA, and other relevant requirements.

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