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API Quality Assurance Director

1 month ago


Kalundborg, Kalundborg Kommune, Denmark Novo Nordisk Full time

We are seeking an experienced API Quality Assurance Director to join our team at Novo Nordisk in Kalundborg. As a key member of our QA Manufacturing II (M2) department, you will be responsible for ensuring the quality of our Active Pharmaceutical Ingredients (API) and intermediates manufactured.

About the Role

The ideal candidate will have a strong background in pharmaceutical industry quality assurance and a passion for optimizing processes and improving quality. You will work closely with our production teams to ensure compliance with GMP regulations and provide guidance on quality-related matters. Your expertise will be invaluable in driving quality excellence throughout our organization.

In this role, you will:

  • Provide leadership and direction on quality assurance activities across API manufacturing sites
  • Develop and implement quality improvement initiatives to enhance our products and processes
  • Collaborate with cross-functional teams to resolve quality-related issues and drive continuous improvement
  • Maintain and improve our quality management system to meet regulatory requirements
About the Department

Our QA Manufacturing II (M2) department is responsible for ensuring the quality of our API and intermediates manufactured. We perform a wide range of quality assurance activities, from handling deviations and change requests to validation and quality support. Our department values collaboration, flexibility, and individual responsibility, and we offer a dynamic work environment that fosters growth and development.

Requirements

To succeed in this role, you will need:

  • A Master's degree in pharmacy, engineering, or natural science
  • At least 3-5 years of experience in pharmaceutical industry quality assurance
  • Strong knowledge of GMP regulations and quality management systems
  • Excellent communication and leadership skills
What We Offer

We offer a competitive salary of $110,000 - $140,000 per year, depending on your level of experience. In addition to a comprehensive benefits package, you will also enjoy:

  • A collaborative and dynamic work environment
  • Opportunities for professional growth and development
  • A competitive bonus structure
  • Flexible working hours and remote work options
About Us

Novo Nordisk is a global leader in diabetes care and biopharmaceuticals, with a commitment to improving the lives of people affected by chronic diseases. We take pride in our innovative approach to healthcare and our dedication to making a positive impact on society.