Executive Quality Leader, Global Trials & PV

Amicus Therapeutics, Inc.; Princeton (NJ); Hybrid; USD 284,000 - 300,000; Full time

Benefits offered by this job

Health insurance

Retirement plan (401K)

Performance-based bonuses

Stock options

Paid time off

Job summary

A global biotechnology company in Princeton, NJ is seeking an Executive Director, Research, Development & Pharmacovigilance Quality. This strategic role involves overseeing quality systems and ensuring regulatory compliance. The ideal candidate has extensive biotech experience, an advanced degree, and strong leadership skills. The position offers a hybrid work arrangement and a competitive salary range of $284,000 to $300,000 with additional benefits.

Qualifications

• Significant experience in biotech/pharmaceutical industry and Quality Leadership in a global environment.
• Strong knowledge and understanding of FDA, EMA, and GLP/GCP/GVP regulations.
• Experience of external auditing and Regulatory Inspections.

Responsibilities

• Develop and maintain robust quality systems for GLP, GCP, and GVP.
• Provide strategic leadership for quality oversight across clinical trials and pharmacovigilance.
• Lead inspection readiness and manage regulatory inspections.

Skills

Leadership

Regulatory Compliance

Quality Management

Analytical Problem Solving

Interpersonal Communication

Education

Advanced degree in Pharmacy, Chemistry, Biosciences, or related field

Job description

A global biotechnology company in Princeton, NJ is seeking an Executive Director, Research, Development & Pharmacovigilance Quality. This strategic role involves overseeing quality systems and ensuring regulatory compliance. The ideal candidate has extensive biotech experience, an advanced degree, and strong leadership skills. The position offers a hybrid work arrangement and a competitive salary range of $284,000 to $300,000 with additional benefits.