Compliance and Regulatory Affairs Manager

15 hours ago


Stockholm, Stockholm, Sweden Karo Healthcare Full time
About This Role

We're seeking an experienced Product Quality Manager to join our team in Stockholm. As a key member of our Quality Assurance team, you will play a crucial role in ensuring the compliance and efficiency of our global quality management system.

The ideal candidate will have at least 5 years of experience in the pharmaceutical or medical devices industry and possess strong alignment with our values: professionalism, honesty, accuracy, and integrity.

Key Responsibilities:
  • Evaluate, qualify, manage, and control suppliers while acting as a QA representative in Technology Transfer projects.
  • Take on project leadership roles and contribute to setting up structures for a project-driven work environment within the Quality Assurance function.
  • Ensure compliant and efficient processes for supplier control in the Karo Global QMS.
  • Secure efficient compliance to global processes and foster relationships with our supplier base.
  • Manage CMOs in accordance with GDP and GMP directives and ensure product compliance after release, including prior deviation handling and follow-up.
  • Act as a process owner for some of the Global QA teams' processes.
Authorities:
  • Ensure product compliance with Directive 2001/83/EC in outsourced activities.
  • Plan, lead audits, and sign off audit reports.
  • Participate in internal audits and approve deviations, change controls, PQRs, specifications, analytical methods, and GMP documents.
  • Issue and/or approve regulatory documents (Modul 3) and co-sign QA-Agreements when applicable.
  • Decide on final disposition of returned, rejected, recalled, or falsified products, and approve returns to saleable stock.


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