Global Responsible Person Manager

2 maanden geleden

Hapert, Noord-Brabant, Nederland Abacus Medicine Voltijd

Overview:

Abacus Medicine Group is seeking a skilled Group RP Manager to oversee a global team dedicated to ensuring the highest standards in the supply of EU medicinal products. This pivotal role is based in our Copenhagen headquarters and involves regular travel to various international locations.

Role Responsibilities:

As the Group RP Manager, you will take charge of the daily operations of Responsible Persons (RPs) across multiple countries, including but not limited to Denmark, Hungary, Germany, Finland, the Netherlands, Hong Kong, Austria, the United States, Switzerland, the United Kingdom, and Ireland. Your responsibilities will encompass maintaining operational quality for the supply of medicinal products within the EU.

You will also bear legal responsibility for the statutory and routine functions associated with the RP roles, necessitating prior experience in a similar capacity.

Key Qualifications:

  • Proven leadership and management skills
  • Understanding of cultural diversity and inclusive leadership practices
  • Familiarity with global Good Distribution Practice (GDP) guidelines; knowledge of Good Manufacturing Practice (GMP) is advantageous
  • This position reports directly to the QA Director at Abacus Medicine Group.

Main Duties:

  • Supervise the global RP team
  • Collaborate with other QA leaders to ensure effective communication and oversight
  • Pursue excellence in quality and continuous improvement initiatives
  • Coordinate and execute recall operations for medicinal products as necessary
  • Manage quality or distribution complaints effectively
  • Approve suppliers and customers as per regulatory requirements
  • Sanction subcontracted activities that may influence GDP compliance
  • Regularly assess GDP suppliers
  • Ensure self-inspections are conducted at scheduled intervals, implementing corrective actions as needed
  • Maintain ongoing communication with various commercial entities within the Abacus Medicine Group

Candidate Profile:

  • Experience in Quality Assurance or a related field within the pharmaceutical sector
  • Minimum of 5 years in a managerial role, with experience in remote team management considered a plus
  • Familiarity with establishing new wholesale licenses is preferred
  • Background as a Responsible Person
  • Comprehensive knowledge of the current EU Guide to GDP, WHO distribution practices, and FDA GDP guidelines
  • Strong understanding of Quality Risk Management principles
  • Demonstrated experience in facilitating regulatory inspections
  • Proficient in English

Team Environment:

The Quality Assurance organization is primarily based in Hungary, the Netherlands, and Denmark, comprising approximately 100 employees, with a significant portion located in Hungary.

Additional Information:

For further inquiries regarding this position, please reach out to the Global QA Director.

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