Executive Director, Head of Quality

Amicus Therapeutics, Inc.

Lead the development and maintenance of GLP/GCP/GVP quality systems while ensuring compliance with FDA and EMA regulations.

Last checked on June 18, 2026. We may earn a commission when you click through.

This position offers a significant opportunity for experienced quality assurance professionals looking to influence high-stakes research and development. However, it demands a deep understanding of complex regulations, which may deter less experienced candidates.

✓ Opportunity to shape quality systems ✓ Engagement with high-level regulatory bodies ✓ Leadership role within a pioneering company

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Executive Director, Head of Quality

Amicus Therapeutics, Inc.

Updated 1 month ago

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Princeton

About this role

Lead the development and maintenance of GLP/GCP/GVP quality systems while ensuring compliance with FDA and EMA regulations.

About the Company

Amicus Therapeutics, Inc. is a biotechnology company focused on developing therapies for rare diseases, leveraging innovative research and technology.

Key Highlights

✓ Strong knowledge of FDA, EMA, and international regulations
✓ Proven experience in quality system management
✓ Focus on risk management and quality governance
✓ Leadership in KPI tracking and management reporting

💡 Honest Take: This role is ideal for seasoned professionals with a understanding of regulatory standards in the pharmaceutical industry.

Pros

✓ Opportunity to shape quality systems
✓ Engagement with high-level regulatory bodies
✓ Leadership role within a pioneering company
✓ Potential for impact on patient outcomes

Cons

✗ High expectations and pressure in a demanding field
✗ Limited remote work flexibility
✗ Requires extensive regulatory knowledge
✗ Potentially long hours

Best For: Ideal for those with a passion for quality assurance in pharmaceuticals and the ability to navigate complex compliance landscapes.

Watch Out: Candidates should be prepared for a rigorous interview process focused on regulatory expertise and leadership skills.

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What Customers Say

Feedback from employees highlights a challenging yet rewarding work environment, emphasizing the importance of regulatory knowledge.

Expert Review

The Executive Director role at Amicus Therapeutics represents a critical leadership position withquality assurance. With responsibilities centered around GLP, GCP, and GVP quality systems, this position is essential for ensuring compliance with FDA and EMA standards. The company emphasizes the importance of risk management and quality governance, making this a pivotal role in their research and development initiatives.

Prospective candidates should note that the expectations are high. The position demands a thorough understanding of complex regulatory frameworks but also the ability to implement effective quality systems. This is not a role for the faint-hearted; it requires a proven track record in quality management and a strategic mindset.

while the opportunity to lead and influence change is significant, the role may involve long hours and a fast-paced work environment. The potential for impact on patient outcomes can be a motivating factor, but it's crucial for applicants to consider their readiness for the challenges ahead. For more information, visit Amicus Therapeutics' official site.

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