Product Management Quality Specialist

3 days ago


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

Karo Healthcare is a dynamic and growing company that empowers people to make intelligent health decisions. With a wide-ranging portfolio across seven categories, we own and sell over 80 brands in about 90 countries. Our core belief drives our growth strategy, blending organic expansion and M&A.

As a Product Quality Manager at Karo Healthcare, you will be part of an exciting journey. We are currently looking for a professional to join our office in Stockholm.

Key Responsibilities
  • Evaluate and manage suppliers, ensuring compliant and efficient processes to verify supplier control in the Karo Global QMS.
  • Lead projects and collaborate with QA teams to set up structures for project-driven work within the function.
  • Secure compliance to global processes and build relationships with Karo's supplier base.
  • Manage CMOs in accordance with GDP and GMP regulations, including PQR management, change control, and CAPA management.
  • Act as a process owner for some Global QA team processes.
Auditorial Authorities
  • Ensure product compliance with EU directives 2001/83/EC in outsourced activities.
  • Plan, lead, and sign off on audits.
  • Participate in internal audit programs as an auditor.
  • Approve and close deviations, change controls, PQRs, and GMP documents issued by CMOs.
  • Issue and/or approve regulatory documents (Modul 3).
Requirements
  • Bachelor's degree in a scientific or technical field required; Master's degree preferred.
  • At least 5 years of experience in the pharmaceutical or medical devices industry.
  • Fluency in English is essential; Swedish is a plus.
  • Strong alignment with Karo values: professionalism, honesty, accuracy, and integrity.
  • Committed to ethical conduct and following rules and regulations.


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