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Quality Assurance Director

2 weeks ago

Cork, Cork, Ireland BioMarin International Limited Full time

BioMarin International Limited is a pioneering company in the development of innovative therapies for rare genetic diseases. Our commitment to advancing life-changing treatments requires a highly skilled and dedicated team of professionals who share our passion for innovation and excellence.

Key Responsibilities

The Quality Assurance Director is responsible for ensuring the highest standards of quality and compliance across our manufacturing sites. Key responsibilities include:

  • Developing and implementing site-specific quality systems and procedures
  • Leading the quality function team to ensure timely resolution of quality system issues and product disposition
  • Maintaining effective relationships with regulatory authorities and stakeholders

In addition to these core responsibilities, the Quality Assurance Director will also:

  • Collaborate with cross-functional teams to drive continuous improvement initiatives
  • Ensure regulatory compliance and maintain effective quality management systems
  • Mentor and develop a high-performing team of quality professionals

To succeed in this challenging and rewarding role, you will need to possess:

  • A minimum of 15 years' experience in the pharmaceutical industry, preferably in Operations or Quality & Compliance roles
  • Advanced degree in pharmaceutical science, biology, chemistry, engineering, or a related field
  • Demonstrated knowledge of US, European, and global cGMPs, as well as inspectional trends and industry quality assurance practices

We offer a competitive compensation package and opportunities for growth and professional development within a talented team of professionals committed to making a meaningful impact on patients' lives.