GxP e-Compliance Director

2 days ago


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

The ideal candidate will lead and manage the Computer System Validation (CSV) process, ensuring e-compliance of GxP systems. This role involves overseeing Quality Data Stewards, evaluating and approving high-level quality concepts and documents, and supporting CSV inspections and internal audits.

Responsibilities
  • Ensure eCompliance: Oversee GxP system lifecycle management, manage Quality Data Stewards, evaluate and approve high-level quality concepts and documents, and support Computerized System Validation (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.
  • Digital Quality Roadmap: Develop and drive the digital Quality roadmap and process quality automation across the GxP arena. Provide strategic leadership in the digital transformation of quality processes.
Qualifications
  • 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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