Quality Compliance Officer (On-site)

Copenhagen, Capital Region
Posted 4 days ago
Healthcare

About the role

Job summary

This role involves providing quality oversight and ensuring compliance with Wholesale Distribution Licence requirements and Good Distribution Practice (GDP) regulations. The Quality Compliance Officer will play a vital role in maintaining product quality, patient safety, and regulatory compliance across multiple entities.

Qualifications

  • Scientific Bachelor's degree or equivalent qualification.
  • Eligible for immediate registration as a Responsible Person.
  • Strong experience within GDP-regulated pharmaceutical environments.

Responsibilities

  • Serve as the Quality Compliance Officer and Responsible Person (RP) for Wholesale Distribution Licence activities in accordance with GDP requirements.
  • Ensure adherence to applicable regulatory and quality standards.
  • Support inspection readiness and conduct regulatory inspections.
  • Oversee third-party distribution providers and outsourced activities.
  • Manage quality incidents, compliance risks, and product recall activities.
  • Develop and maintain policies, procedures, and training programs.
  • Provide expert advice on regulatory and compliance issues.
  • Collaborate with internal and external stakeholders to promote continuous improvement.

Skills

  • Strong communication, planning, and organizational skills.
  • Ability to influence stakeholders and make effective decisions in complex situations.

Tools

  • Familiarity with quality systems, compliance frameworks, and risk management.
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