Regulated Industry Compliance Specialist

10 hours ago


Køge, Køge Kommune, Denmark Novo Nordisk Full time

About the Role

We are seeking a highly skilled Regulated Industry Compliance Specialist to join our Inbound Supply team.

As a key member of our procurement team, you will be responsible for ensuring GMP documentation requirements for suppliers are meticulously managed and in compliance with industry standards.

The ideal candidate will have a strong understanding of GMP standards and documentation requirements, with the ability to ensure supplier compliance and maintain accurate records.

Key Responsibilities:

  • Manage GMP documentation related to suppliers and materials in Inbound Supply, serving as qualification responsible and writer for both packaging and raw materials.
  • Improve Inbound Supply processes to meet quality and performance goals, and develop strategies to enhance overall supplier compliance.
  • Support Inbound Supply with GMP-related tasks, manage change notifications related to Inbound Supply materials, and foster a quality mindset within the team.
  • Assist in the evaluation and selection of suppliers, focusing on their adherence to GMP documentation requirements, and participate in contract negotiations and documentation of new suppliers and materials.
  • Monitor and maintain a robust documentation system to track supplier GMP compliance, ensuring accuracy and completeness of records, and handle Deviation (DV) and Change Request (CR) cases related to Inbound Supply.

What We Offer

We offer a competitive salary of approximately $85,000 per year, depending on experience. Our benefits package includes comprehensive health insurance, generous paid time off, and opportunities for professional growth and development.

About Us

Novo Nordisk Pharmatech A/S is a leading global supplier of high-quality ingredients for the biopharmaceutical and pharmaceutical industries. We supply products such as recombinant insulin for cell growth media and pharmaceutical grade quaternary ammonium compounds as well as raw materials for Novo Nordisk A/S.

Requirements

To be successful in this role, you will need:

  • A bachelor's degree in Life Sciences or a related field.
  • Several years of experience in procurement, supply chain management, or quality management with a focus on GMP documentation within a regulated industry.
  • Excellent communication skills in English, with the ability to collaborate effectively with cross-functional teams and external stakeholders.

Location

This role is based in Køge, Denmark, a vibrant and growing community with easy access to Copenhagen.



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